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Trial record 27 of 283 for:    Tumor infiltrating lymphocytes

Cell Therapy for Metastatic Melanoma Using CD8 Enriched Tumor Infiltrating Lymphocytes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01236573
Recruitment Status : Terminated (Unexpected toxicities, likely due to TIL/IL-12 & low % of durable responses.)
First Posted : November 8, 2010
Results First Posted : October 26, 2015
Last Update Posted : November 26, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Skin Cancer
Metastatic Melanoma
Interventions Drug: Fludarabine
Drug: Cyclophosphamide
Biological: IL-12 transduced TIL
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1) Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1) Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1) Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1) Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1) Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1) Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1) Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1) Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1) Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1) Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)
Hide Arm/Group Description

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Period Title: Phase 1-Dose Escalation-Cohorts 1-4
Started 1 1 6 1 0 0 0 0 0 0 0
Completed 1 1 6 1 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Phase 1-Dose Escalation-Cohorts 5-10
Started 0 0 0 0 1 4 3 3 4 4 0
Completed 0 0 0 0 1 4 2 3 2 3 0
Not Completed 0 0 0 0 0 0 1 0 2 1 0
Reason Not Completed
Death during treatment             0             0             0             0             0             0             1             0             1             1             0
Not treated             0             0             0             0             0             0             0             0             1             0             0
Period Title: Phase 2- MTD/Anti-IL-12 Cells-Cohort 11
Started 0 0 0 0 0 0 0 0 0 0 6
Completed 0 0 0 0 0 0 0 0 0 0 5
Not Completed 0 0 0 0 0 0 0 0 0 0 1
Reason Not Completed
Did not receive cells             0             0             0             0             0             0             0             0             0             0             1
Arm/Group Title Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1) Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1) Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1) Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1) Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1) Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1) Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1) Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1) Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1) Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1) Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2) Total
Hide Arm/Group Description

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Total of all reporting groups
Overall Number of Baseline Participants 1 1 6 1 1 4 3 3 4 4 6 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 6 participants 1 participants 1 participants 4 participants 3 participants 3 participants 4 participants 4 participants 6 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
6
 100.0%
1
 100.0%
1
 100.0%
4
 100.0%
3
 100.0%
3
 100.0%
3
  75.0%
3
  75.0%
5
  83.3%
31
  91.2%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
1
  25.0%
1
  16.7%
3
   8.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 6 participants 1 participants 1 participants 4 participants 3 participants 3 participants 4 participants 4 participants 6 participants 34 participants
56.0  (0) 50.0  (0) 39.0  (11.5) 48.0  (0) 60.0  (0) 57.3  (10.9) 49.0  (14.5) 56.0  (9.6) 53.5  (16.2) 55.8  (12.2) 49.3  (16.5) 50.7  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 6 participants 1 participants 1 participants 4 participants 3 participants 3 participants 4 participants 4 participants 6 participants 34 participants
Female
1
 100.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
1
  25.0%
2
  66.7%
1
  33.3%
1
  25.0%
2
  50.0%
0
   0.0%
9
  26.5%
Male
0
   0.0%
1
 100.0%
5
  83.3%
1
 100.0%
1
 100.0%
3
  75.0%
1
  33.3%
2
  66.7%
3
  75.0%
2
  50.0%
6
 100.0%
25
  73.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 6 participants 1 participants 1 participants 4 participants 3 participants 3 participants 4 participants 4 participants 6 participants 34 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
1
  25.0%
0
   0.0%
2
   5.9%
Not Hispanic or Latino
1
 100.0%
1
 100.0%
6
 100.0%
1
 100.0%
1
 100.0%
4
 100.0%
3
 100.0%
2
  66.7%
4
 100.0%
3
  75.0%
6
 100.0%
32
  94.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 6 participants 1 participants 1 participants 4 participants 3 participants 3 participants 4 participants 4 participants 6 participants 34 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
1
 100.0%
1
 100.0%
6
 100.0%
1
 100.0%
1
 100.0%
4
 100.0%
3
 100.0%
3
 100.0%
4
 100.0%
3
  75.0%
6
 100.0%
33
  97.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
1
   2.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 6 participants 1 participants 1 participants 4 participants 3 participants 3 participants 4 participants 4 participants 6 participants 34 participants
1 1 6 1 1 4 3 3 4 4 6 34
1.Primary Outcome
Title Maximum Tolerated Dose (MTD)
Hide Description The MTD was determined by evaluating dose limiting toxicities (DLT) of participants that received increasing doses of intravenous infusion of IL-12 gene transduced tumor infiltrating lymphocytes (TIL) (i.e., 1x10^6, 3x10^6, 3x10^7, 1x10^7, 3x10^7, 1x10^8, 3x10^8, 1x10^9, and 3x10^9) in cohorts 1-10. Maximum tolerated cell dose is the highest dose at which </= 1 of 6 patients experienced a DLT (i.e. grade 2 or greater allergic reaction)).
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Phase I Participants
Hide Arm/Group Description:
All phase I participants who received at least one dose intravenously of CD8 + TIL expressing IL-12 in Groups 1-4, and Bulk TIL expressing IL-12 in Groups 5-10 (i.e., CD8 + TIL expressing IL-12 1x10^6, CD8 + TIL expressing IL-12 3x10^6, CD8 + TIL expressing IL-12 3x10^7, CD8 + TIL expressing IL-12 3x10^7, Bulk TIL expressing IL-12 1x10^7, Bulk TIL expressing IL-12 3x10^7, Bulk TIL expressing IL-12 1x10^8, Bulk TIL expressing IL-12 3x10^8, Bulk TIL expressing IL-12 1x10^9, and Bulk TIL expressing IL-12 3x10^9) respectively.
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: Cells
1,000,000,000
2.Primary Outcome
Title Response (Complete Response (CR) + Partial Response (PR)) to Therapy
Hide Description Response was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline um LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1) Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1) Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1) Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1) Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1) Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1) Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1) Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1) Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1) Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1) Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)
Hide Arm/Group Description:

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Overall Number of Participants Analyzed 1 1 6 1 1 4 3 3 4 4 6
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 0 0 0 0 0 0 0 0 0 1 0
Partial Response (PR) 0 0 0 0 0 0 0 0 1 3 1
Progressive Disease (PD) 1 1 6 0 1 4 2 2 2 0 3
Not Assessed (NA) 0 0 0 1 0 0 1 1 1 0 1
Not Evaluable (NE) 0 0 0 0 0 0 0 0 0 0 1
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time Frame 49 months and 20 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1) Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1) Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1) Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1) Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1) Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1) Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1) Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1) Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1) Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1) Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)
Hide Arm/Group Description:

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Overall Number of Participants Analyzed 1 1 6 1 1 4 3 3 4 4 6
Measure Type: Number
Unit of Measure: participants
1 1 6 1 1 4 3 3 4 4 6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1) Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1) Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1) Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1) Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1) Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1) Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1) Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1) Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1) Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1) Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)
Hide Arm/Group Description

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.

All-Cause Mortality
Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1) Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1) Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1) Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1) Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1) Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1) Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1) Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1) Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1) Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1) Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1) Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1) Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1) Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1) Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1) Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1) Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1) Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1) Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1) Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1) Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/1 (0.00%)      2/6 (33.33%)      0/1 (0.00%)      0/1 (0.00%)      0/4 (0.00%)      1/3 (33.33%)      1/3 (33.33%)      1/4 (25.00%)      1/4 (25.00%)      2/6 (33.33%)    
Blood and lymphatic system disorders                       
Platelets  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Hemoglobin  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
General disorders                       
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders                       
Bilirubin (Hyperbilirubinemia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Creatinine  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
ALT, SGPT (serum glutamic pyruvic transaminase)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 2/6 (33.33%)  2
Respiratory, thoracic and mediastinal disorders                       
Hypoxia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Dyspnea (shortness of breath)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Pneumonitis/pulmonary infiltrates  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Vascular disorders                       
Thrombosis/thrombus/embolism  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Thrombotic microangiopathy  1 [1]  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
(e.g., thrombotic thrombocytopenic purpura (TTP) or hemolytic uremic syndrome (HUS)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1) Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1) Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1) Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1) Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1) Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1) Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1) Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1) Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1) Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1) Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/1 (100.00%)      6/6 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      4/4 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      4/4 (100.00%)      4/4 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders                       
PTT (Partial Thromboplastin TIme)  1  1/1 (100.00%)  1 1/1 (100.00%)  1 4/6 (66.67%)  4 1/1 (100.00%)  1 1/1 (100.00%)  1 2/4 (50.00%)  2 2/3 (66.67%)  2 2/3 (66.67%)  2 3/4 (75.00%)  3 1/4 (25.00%)  1 0/6 (0.00%)  0
Hemoglobin  1  1/1 (100.00%)  1 1/1 (100.00%)  1 6/6 (100.00%)  6 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 2/3 (66.67%)  2 3/3 (100.00%)  3 4/4 (100.00%)  4 4/4 (100.00%)  4 3/6 (50.00%)  3
Leukocytes (total WBC)  1  1/1 (100.00%)  1 1/1 (100.00%)  1 6/6 (100.00%)  6 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 3/3 (100.00%)  3 3/3 (100.00%)  3 4/4 (100.00%)  4 4/4 (100.00%)  4 6/6 (100.00%)  6
Lymphopenia  1  1/1 (100.00%)  1 1/1 (100.00%)  1 6/6 (100.00%)  6 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 3/3 (100.00%)  3 3/3 (100.00%)  3 4/4 (100.00%)  4 4/4 (100.00%)  4 6/6 (100.00%)  6
Neutrophils/granulocytes (ANC/AGC)  1  1/1 (100.00%)  1 1/1 (100.00%)  1 6/6 (100.00%)  6 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 3/3 (100.00%)  3 3/3 (100.00%)  3 4/4 (100.00%)  4 3/4 (75.00%)  3 6/6 (100.00%)  6
Platelets  1  1/1 (100.00%)  1 1/1 (100.00%)  1 5/6 (83.33%)  5 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 2/3 (66.67%)  2 3/3 (100.00%)  3 4/4 (100.00%)  4 4/4 (100.00%)  4 6/6 (100.00%)  6
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  1/1 (100.00%)  1 0/1 (0.00%)  0 5/6 (83.33%)  5 1/1 (100.00%)  1 1/1 (100.00%)  1 3/4 (75.00%)  3 1/3 (33.33%)  1 3/3 (100.00%)  3 3/4 (75.00%)  3 4/4 (100.00%)  4 0/6 (0.00%)  0
Coagulation-Other (thrombotic microangiopathy)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Edema:limb  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Cardiac disorders                       
Supraventricular and nodal arrhythmia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/4 (50.00%)  2 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Pleural effusion (non-malignant)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 1/6 (16.67%)  1
Hypertension  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Hypotension  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/4 (25.00%)  1 0/6 (0.00%)  0
Eye disorders                       
Vision-blurred vision  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Gastrointestinal disorders                       
Nausea  1  1/1 (100.00%)  1 1/1 (100.00%)  1 4/6 (66.67%)  4 1/1 (100.00%)  1 1/1 (100.00%)  1 3/4 (75.00%)  3 3/3 (100.00%)  3 3/3 (100.00%)  3 4/4 (100.00%)  4 4/4 (100.00%)  4 3/6 (50.00%)  3
Vomiting  1  1/1 (100.00%)  1 0/1 (0.00%)  0 4/6 (66.67%)  4 1/1 (100.00%)  1 1/1 (100.00%)  1 3/4 (75.00%)  3 3/3 (100.00%)  3 3/3 (100.00%)  3 3/4 (75.00%)  3 1/4 (25.00%)  1 2/6 (33.33%)  2
Dry mouth/salivary gland (xerostomia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Hemorrhage, GI  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 2/3 (66.67%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal -Other (bloating)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Gastritis (including bile reflux gastritis)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Taste alteration (dysgeusia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Constipation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 1/6 (16.67%)  1
Diarrhea  1  0/1 (0.00%)  0 0/1 (0.00%)  0 2/6 (33.33%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 2/3 (66.67%)  2 2/3 (66.67%)  2 2/4 (50.00%)  2 3/4 (75.00%)  3 2/6 (33.33%)  2
Mucositis/stomatitis (clinical exam)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 1/6 (16.67%)  1
Anorexia  1  0/1 (0.00%)  0 1/1 (100.00%)  1 6/6 (100.00%)  6 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 3/3 (100.00%)  3 2/3 (66.67%)  2 2/4 (50.00%)  2 2/4 (50.00%)  2 1/6 (16.67%)  1
General disorders                       
Pain  1  1/1 (100.00%)  1 1/1 (100.00%)  1 6/6 (100.00%)  6 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 3/3 (100.00%)  3 3/3 (100.00%)  3 3/4 (75.00%)  3 4/4 (100.00%)  4 3/6 (50.00%)  3
Death not associated with CTCAE term  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Weight gain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Fatigue (asthenia, lethargy, malaise)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 4/6 (66.67%)  4 0/1 (0.00%)  0 0/1 (0.00%)  0 2/4 (50.00%)  2 2/3 (66.67%)  2 3/3 (100.00%)  3 3/4 (75.00%)  3 4/4 (100.00%)  4 2/6 (33.33%)  2
Rigors/chills  1  1/1 (100.00%)  1 0/1 (0.00%)  0 3/6 (50.00%)  3 1/1 (100.00%)  1 0/1 (0.00%)  0 2/4 (50.00%)  2 1/3 (33.33%)  1 2/3 (66.67%)  2 3/4 (75.00%)  3 3/4 (75.00%)  3 1/6 (16.67%)  1
Sweating (diaphoresis)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 3/6 (50.00%)  3 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 2/3 (66.67%)  2 2/4 (50.00%)  2 1/4 (25.00%)  1 1/6 (16.67%)  1
Weight loss  1  0/1 (0.00%)  0 0/1 (0.00%)  0 4/6 (66.67%)  4 0/1 (0.00%)  0 0/1 (0.00%)  0 3/4 (75.00%)  3 2/3 (66.67%)  2 0/3 (0.00%)  0 1/4 (25.00%)  1 1/4 (25.00%)  1 1/6 (16.67%)  1
Pain-Other (generalized pain)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Hepatobiliary disorders                       
Liver dysfunction/failure (clinical)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Pancreatitis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/4 (25.00%)  1 0/6 (0.00%)  0
Immune system disorders                       
Cytokine release syndrome/acute infusion reaction  1  0/1 (0.00%)  0 0/1 (0.00%)  0 2/6 (33.33%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Allergic reaction/hypersensitivity (including drug fever)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations                       
Febrile neutropenia  1 [1]  0/1 (0.00%)  0 1/1 (100.00%)  1 2/6 (33.33%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0 4/4 (100.00%)  4 2/3 (66.67%)  2 3/3 (100.00%)  3 4/4 (100.00%)  4 4/4 (100.00%)  4 5/6 (83.33%)  5
Infection  1  0/1 (0.00%)  0 1/1 (100.00%)  1 2/6 (33.33%)  2 1/1 (100.00%)  1 1/1 (100.00%)  1 3/4 (75.00%)  3 2/3 (66.67%)  2 1/3 (33.33%)  1 1/4 (25.00%)  1 1/4 (25.00%)  1 1/6 (16.67%)  1
Metabolism and nutrition disorders                       
Albumin, serum-low (hypoalbuminemia)  1  1/1 (100.00%)  1 1/1 (100.00%)  1 6/6 (100.00%)  6 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 3/3 (100.00%)  3 3/3 (100.00%)  3 4/4 (100.00%)  4 4/4 (100.00%)  4 1/6 (16.67%)  1
Sodium, serum-high (hypernatremia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Calcium, serum-high (hypercalcemia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/4 (25.00%)  1 0/6 (0.00%)  0
Potassium, serum-low (hypokalemia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 2/6 (33.33%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 2/4 (50.00%)  2 1/4 (25.00%)  1 0/6 (0.00%)  0
Alkaline phosphatase  1  1/1 (100.00%)  1 0/1 (0.00%)  0 3/6 (50.00%)  3 1/1 (100.00%)  1 0/1 (0.00%)  0 4/4 (100.00%)  4 2/3 (66.67%)  2 1/3 (33.33%)  1 3/4 (75.00%)  3 4/4 (100.00%)  4 2/6 (33.33%)  2
Bilirubin (hyperbilirubinemia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 1/1 (100.00%)  1 0/1 (0.00%)  0 3/4 (75.00%)  3 1/3 (33.33%)  1 1/3 (33.33%)  1 0/4 (0.00%)  0 1/4 (25.00%)  1 1/6 (16.67%)  1
Creatinine  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 3/4 (75.00%)  3 1/6 (16.67%)  1
Calcium, serum-low (hypocalcemia)  1  1/1 (100.00%)  1 0/1 (0.00%)  0 5/6 (83.33%)  5 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 3/3 (100.00%)  3 3/3 (100.00%)  3 3/4 (75.00%)  3 2/4 (50.00%)  2 1/6 (16.67%)  1
Magnesium, serum-low (hypomagnesemia)  1  1/1 (100.00%)  1 1/1 (100.00%)  1 6/6 (100.00%)  6 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 3/3 (100.00%)  3 3/3 (100.00%)  3 2/4 (50.00%)  2 2/4 (50.00%)  2 0/6 (0.00%)  0
Phosphate, serum-low (hypophosphatemia)  1  1/1 (100.00%)  1 1/1 (100.00%)  1 6/6 (100.00%)  6 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 1/3 (33.33%)  1 3/3 (100.00%)  3 4/4 (100.00%)  4 3/4 (75.00%)  3 2/6 (33.33%)  2
Sodium, serum-low (hyponatremia)  1  1/1 (100.00%)  1 1/1 (100.00%)  1 2/6 (33.33%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0 3/4 (75.00%)  3 1/3 (33.33%)  1 3/3 (100.00%)  3 3/4 (75.00%)  3 1/4 (25.00%)  1 0/6 (0.00%)  0
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  0/1 (0.00%)  0 1/1 (100.00%)  1 3/6 (50.00%)  3 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 1/3 (33.33%)  1 2/3 (66.67%)  2 4/4 (100.00%)  4 4/4 (100.00%)  4 2/6 (33.33%)  2
ALT, SGPT (serum glutamic pyruvic transaminase)  1  0/1 (0.00%)  0 1/1 (100.00%)  1 4/6 (66.67%)  4 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 2/3 (66.67%)  2 2/3 (66.67%)  2 4/4 (100.00%)  4 4/4 (100.00%)  4 3/6 (50.00%)  3
Magnesium, serum-high (hypermagnesemia)  1  0/1 (0.00%)  0 1/1 (100.00%)  1 2/6 (33.33%)  2 1/1 (100.00%)  1 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Uric acid, serum-high (hyperuricemia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders                       
Fracture  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Nervous system disorders                       
Memory impairment  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Hemorrhage, CNS  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Confusion  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/4 (50.00%)  2 0/6 (0.00%)  0
Dizziness  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 4/4 (100.00%)  4 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Mood alteration  1  0/1 (0.00%)  0 0/1 (0.00%)  0 2/6 (33.33%)  2 0/1 (0.00%)  0 1/1 (100.00%)  1 2/4 (50.00%)  2 1/3 (33.33%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 1/4 (25.00%)  1 0/6 (0.00%)  0
Psychosis (hallucinations/delusions)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Neuropathy:sensory  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Renal and urinary disorders                       
Hemorrhage, GU  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Renal failure  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                       
Hemorrhage, pulmonary/upper respiratory  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/1 (100.00%)  1 1/1 (100.00%)  1 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Hiccoughs (hiccups, singultus)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Dyspnea (shortness of breath)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 2/6 (33.33%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 2/4 (50.00%)  2 0/6 (0.00%)  0
Hypoxia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Cough  1  0/1 (0.00%)  0 0/1 (0.00%)  0 3/6 (50.00%)  3 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 2/3 (66.67%)  2 1/3 (33.33%)  1 0/4 (0.00%)  0 1/4 (25.00%)  1 1/6 (16.67%)  1
Pericardial effusion (non-malignant)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders                       
Dry skin  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 2/6 (33.33%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Hair loss/alopecia (scalp or body)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Rash/desquamation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 3/6 (50.00%)  3 1/1 (100.00%)  1 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 2/6 (33.33%)  2
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Hypopigmentation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Pruritis/itching  1  0/1 (0.00%)  0 0/1 (0.00%)  0 2/6 (33.33%)  2 0/1 (0.00%)  0 1/1 (100.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 2/4 (50.00%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0
Flushing  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Vascular disorders                       
Thrombosis/thrombus/embolism  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Vascular-Other (anasarca)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
(fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0x10e9/L, fever >=38.5 degrees C)
Due to the unexpected toxicities, likely attributable to the tumor infiltrating lymphocytes (TIL) transduced with IL-12, and low percentage of durable responses, we decided to close this study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Steven Rosenberg
Organization: National Cancer Institute
Phone: 301-496-4164
Responsible Party: Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01236573     History of Changes
Other Study ID Numbers: 110011
11-C-0011
First Submitted: November 5, 2010
First Posted: November 8, 2010
Results First Submitted: August 20, 2015
Results First Posted: October 26, 2015
Last Update Posted: November 26, 2015