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Trial record 14 of 283 for:    Tumor infiltrating lymphocytes

Immunotherapy Using 41BB Selected Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT02111863
Recruitment Status : Terminated (Study terminated due to low accrual and change in research focus.)
First Posted : April 11, 2014
Results First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Melanoma
Skin Cancer
Interventions Drug: Aldesleukin
Drug: Fludarabine
Drug: Cyclophosphamide
Biological: 4-1BB Selected Tumor Infiltrating Lymphocytes (TIL)
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lymphocyte Depleting Prep Regimen
Hide Arm/Group Description

Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.

Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.

4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine).

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Lymphocyte Depleting Prep Regimen
Hide Arm/Group Description

Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.

Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.

4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine).

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
49.8  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
3
  50.0%
Male
3
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
6
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
6
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
 100.0%
1.Primary Outcome
Title Count of Participants With Serious and Non-Serious Adverse Events
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame 2 years and 59 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lymphocyte Depleting Prep Regimen
Hide Arm/Group Description:

Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.

Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.

4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine).

Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
6
 100.0%
2.Primary Outcome
Title Objective Response Rate of Patients With Metastatic Melanoma
Hide Description Objective response is defined as complete response + partial response and was assessed 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 sum LD. Progressive disease (PD) is at least a 20% increase in the sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Time Frame approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lymphocyte Depleting Prep Regimen
Hide Arm/Group Description:

Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.

Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.

4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine).

Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage of participants
Progressive Disease 83.33
Partial Response 16.67
Complete Response 0
Stable Disease 0
3.Secondary Outcome
Title Overall Survival (OS) of Patients Receiving a Lymphocyte Depleting Preparative Regimen
Hide Description OS is defined as the time between the first day of treatment to the day of death or date last known alive.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lymphocyte Depleting Prep Regimen
Hide Arm/Group Description:

Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.

Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.

4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine).

Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: months
12
(2 to 35)
Time Frame 2 years and 59 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lymphocyte Depleting Prep Regimen
Hide Arm/Group Description

Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.

Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.

4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine).

All-Cause Mortality
Lymphocyte Depleting Prep Regimen
Affected / at Risk (%)
Total   0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lymphocyte Depleting Prep Regimen
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lymphocyte Depleting Prep Regimen
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  4/6 (66.67%)  4
Leukocytes (total WBC)  1  3/6 (50.00%)  3
Lymphopenia  1  6/6 (100.00%)  6
Neutrophils/granulocytes  1  6/6 (100.00%)  6
Platelets  1  6/6 (100.00%)  6
Gastrointestinal disorders   
Distension/bloating, abdominal  1  1/6 (16.67%)  1
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  4/6 (66.67%)  4
Infections and infestations   
Infection  1  2/6 (33.33%)  2
Metabolism and nutrition disorders   
Bilirubin (hyperbilirubinemia)  1  1/6 (16.67%)  1
Nervous system disorders   
Psychosis (hallucinations/delusions)  1  1/6 (16.67%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
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 A. 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: NCT02111863     History of Changes
Other Study ID Numbers: 140062
14-C-0062
First Submitted: April 9, 2014
First Posted: April 11, 2014
Results First Submitted: July 21, 2017
Results First Posted: September 19, 2017
Last Update Posted: September 19, 2017