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T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers

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: NCT02280811
Recruitment Status : Completed
First Posted : November 3, 2014
Results First Posted : August 2, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Christian S. Hinrichs, 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 Vaginal Cancer
Cervical Cancer
Anal Cancer
Penile Cancer
Oropharyngeal Cancer
Interventions Drug: Fludarabine
Drug: Cyclophosphamide
Biological: E6 TCR
Drug: Aldesleukin
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2
Hide Arm/Group Description

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

This is the phase 2 arm that was treated at the MTD determined in the phase 1 portion.

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Period Title: Drug Administration
Started 1 2 1 6 2
Completed 1 2 1 6 2
Not Completed 0 0 0 0 0
Period Title: Retreated at the MTD
Started 0 0 0 0 1 [1]
Completed 0 0 0 0 1
Not Completed 0 0 0 0 0
[1]
Patient originally started in Grp1(HPV-16 E6mTCR PBL 1x10^9+HD IL-2) and was retreated at the MTD.
Arm/Group Title HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2 Total
Hide Arm/Group Description

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Total of all reporting groups
Overall Number of Baseline Participants 1 2 1 6 2 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 1 participants 6 participants 2 participants 12 participants
<=18 years
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%
2
 100.0%
1
 100.0%
5
  83.3%
1
  50.0%
10
  83.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
  50.0%
2
  16.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 2 participants 1 participants 6 participants 2 participants 12 participants
50.0  (0) 34.5  (3.5) 46.0  (0) 53.5  (12.5) 60.0  (14.1) 50.5  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 1 participants 6 participants 2 participants 12 participants
Female
1
 100.0%
2
 100.0%
1
 100.0%
5
  83.3%
1
  50.0%
10
  83.3%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
  50.0%
2
  16.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 1 participants 6 participants 2 participants 12 participants
Hispanic or Latino
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
Not Hispanic or Latino
1
 100.0%
1
  50.0%
1
 100.0%
6
 100.0%
2
 100.0%
11
  91.7%
Unknown or Not Reported
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 2 participants 1 participants 6 participants 2 participants 12 participants
American Indian or Alaska Native
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%
Native Hawaiian or Other Pacific Islander
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%
White
1
 100.0%
1
  50.0%
1
 100.0%
6
 100.0%
2
 100.0%
11
  91.7%
More than one race
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%
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 2 participants 1 participants 6 participants 2 participants 12 participants
1 2 1 6 2 12
Baseline Cancer Types  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 1 participants 6 participants 2 participants 12 participants
Cervical
0
   0.0%
2
 100.0%
1
 100.0%
3
  50.0%
0
   0.0%
6
  50.0%
Anal
0
   0.0%
0
   0.0%
0
   0.0%
2
  33.3%
2
 100.0%
4
  33.3%
Oropharyngeal
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
   8.3%
Vaginal
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD)
Hide Description The MTD is the highest dose at which ≤1 of 6 patients experienced a dose limiting toxicity (DLT) or the highest dose level studied if DLTs are not observed at any of the dose levels.
Time Frame participants were followed for the duration of hospital stay, an average of 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Treated Subjects
Hide Arm/Group Description:
All treated subjects who received at least one dose of human papilloma virus (HPV)-16 E6 monoclonal T cell receptor (mTCR) peripheral blood lymphocytes (PBL) 1x10^9, 1x10^10,1x10^11, >1x10^11 up to 2x10^11 + high-dose (HD) interleukin 2 (IL-2) were included.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: # of cells x 10^11
2
2.Primary Outcome
Title Objective Tumor Response Rate (Complete or Partial Response)
Hide Description Objective tumor response rate is defined as the number of participants with a complete or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2
Hide Arm/Group Description:

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Overall Number of Participants Analyzed 1 2 1 6 2
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 0 0 0 0 0
Partial Response (PR) 0 0 0 2 0
3.Primary Outcome
Title Duration of Response
Hide Description Duration of response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progression is at least a 20% increase in the sum of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame up to one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2
Hide Arm/Group Description:

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Overall Number of Participants Analyzed 1 2 1 6 2
Mean (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
1.5
(0 to 6)
NA [1] 
(NA to NA)
[1]
Participants had no responses.
4.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events
Hide Description Here is the number 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 19 months and 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2
Hide Arm/Group Description:

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Overall Number of Participants Analyzed 1 2 1 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
2
 100.0%
1
 100.0%
6
 100.0%
2
 100.0%
5.Secondary Outcome
Title Number of Participants With a Dose Limiting Toxicity (DLT)
Hide Description A dose limiting toxicity is all Grade 3 and greater toxicities with the exception of myelosuppression, defined as lymphopenia, neutropenia, decreased hemoglobin, and thrombocytopenia, due to chemotherapy preparative regimen. Aldesleukin expected toxicities as defined in Appendix 2 and 3 of the protocol. Expected chemotherapy toxicities as defined in the pharmaceutical information section. Immediate hypersensitivity reactions (excluding symptomatic bronchospasm and grade 4 hypotension) occurring within 2 hours of cell infusion (related to cell infusion) that are reversible to a grade 2 or less within 24 hours of cell administration with standard therapy. Grade 3 fever. Events that are clearly related to the patient's disease.
Time Frame 19 months and 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2
Hide Arm/Group Description:

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Overall Number of Participants Analyzed 1 2 1 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Percentage of Cluster of Differentiation 3 (CD3+) Cells That Are E6 T-Cell Receptor Memory of Circulating T-Cells in Responders and Non-responders
Hide Description Detection of E6 TCR T cells in patients peripheral blood leukocytes (PBL)/apheresis samples by flow cytometry.
Time Frame One month after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
One patient in group HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 did not have research blood collected at one month post infusion, and thus could not examine the cells for that patient at that time point.
Arm/Group Title HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2
Hide Arm/Group Description:

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Overall Number of Participants Analyzed 1 1 1 6 2
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Responders NA [1]  NA [1]  NA [1] 
38
(30.1 to 45.9)
NA [1] 
(NA to NA)
Non-responders
30.7
(30.7 to 30.7)
4.4
(4.4 to 4.4)
12.6
(12.6 to 12.6)
29.9
(10.4 to 44.4)
37.1
(21.7 to 52.5)
[1]
There were no responders in this group so that means they did not have a mean percentage of E6 TCR cells at one month.
7.Secondary Outcome
Title Expression of Programmed Cell Death 1 (PD-1) by Circulating E6 T-Cell Receptor (TCR) T-Cells
Hide Description Presence of PD-1 on circulating lymphocytes by flow cytometry one month after treatment.
Time Frame one month after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
One patient in group HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 did not have research blood collected at one month post infusion, and thus could not examine the cells for that patient at that time point.
Arm/Group Title HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2
Hide Arm/Group Description:

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Overall Number of Participants Analyzed 1 1 1 6 2
Mean (Full Range)
Unit of Measure: % PD-1 circulating lymphocytes
1
(1 to 1)
2
(2 to 2)
3
(3 to 3)
1
(0 to 3.6)
2.2
(0.5 to 3.9)
Time Frame 19 months and 7 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2-Retreatment
Hide Arm/Group Description

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin

Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.

Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

All-Cause Mortality
HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2-Retreatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)      0/2 (0.00%)      0/1 (0.00%)      0/6 (0.00%)      0/2 (0.00%)      0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2-Retreatment
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%)      1/2 (50.00%)      0/1 (0.00%)      2/6 (33.33%)      2/2 (100.00%)      0/1 (0.00%)    
Gastrointestinal disorders             
Diarrhea  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations             
Infection (documented clinically or microbiologically)  1 [1]  0/1 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 2/6 (33.33%)  2 0/2 (0.00%)  0 0/1 (0.00%)  0
Febrile neutropenia  1 [2]  0/1 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 2/2 (100.00%)  2 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Dyspnea (shortness of breath)  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Hemorrhage, pulmonary/upper respiratory::Bronchopulmonary NOS  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Hypoxia  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Obstruction/stenosis of airway::Bronchus  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Prolonged intubation after pulmonary resection (>24 hrs after surgery)  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Blood
[2]
(fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2 HPV-16 E6 mTCR PBL MTD + HD IL-2-Retreatment
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%)      2/2 (100.00%)      1/1 (100.00%)      6/6 (100.00%)      2/2 (100.00%)      1/1 (100.00%)    
Blood and lymphatic system disorders             
Lymphopenia  1  1/1 (100.00%)  1 2/2 (100.00%)  2 1/1 (100.00%)  1 6/6 (100.00%)  6 2/2 (100.00%)  2 1/1 (100.00%)  1
Neutrophils/granulocytes (ANC/AGC)  1  1/1 (100.00%)  1 2/2 (100.00%)  2 1/1 (100.00%)  1 6/6 (100.00%)  6 2/2 (100.00%)  2 1/1 (100.00%)  1
Platelets  1  1/1 (100.00%)  1 2/2 (100.00%)  2 1/1 (100.00%)  1 6/6 (100.00%)  6 2/2 (100.00%)  2 1/1 (100.00%)  1
Cardiac disorders             
Hypotension  1  0/1 (0.00%)  0 0/2 (0.00%)  0 1/1 (100.00%)  1 0/6 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Supraventricular and nodal arrhythmia::Sinus tachycardia  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
Gastrointestinal disorders             
Diarrhea  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
General disorders             
Fatigue  1  1/1 (100.00%)  1 1/2 (50.00%)  1 1/1 (100.00%)  1 1/6 (16.67%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations             
Infection (documented clinically and microbiologically)  1 [1]  1/1 (100.00%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
Febrile neutropenia  1 [2]  0/1 (0.00%)  0 1/2 (50.00%)  1 1/1 (100.00%)  1 1/6 (16.67%)  1 2/2 (100.00%)  2 0/1 (0.00%)  0
Metabolism and nutrition disorders             
Hemoglobin  1  1/1 (100.00%)  1 2/2 (100.00%)  2 1/1 (100.00%)  1 4/6 (66.67%)  4 2/2 (100.00%)  2 1/1 (100.00%)  1
Bilirubin (hyperbilirubinemia)  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Creatinine  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
Nervous system disorders             
Psychosis (hallucinations/delusions)  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Syncope (fainting)  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
Renal and urinary disorders             
Renal/Genitourinary - Other, Acute renal injury  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Dyspnea (shortness of breath)  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 2/6 (33.33%)  2 0/2 (0.00%)  0 0/1 (0.00%)  0
Hypoxia  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 2/6 (33.33%)  2 0/2 (0.00%)  0 0/1 (0.00%)  0
Pleural effusion (non-malignant)  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders             
Rash/desquamation  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
with Grade 3 or 4 neutrophils (ANC<1.0x10e9/L)::Blood
[2]
(fever of unknown origin without clinically or microbiologically documented infection)(ANC<1.0 x 10e9/L, fever>=38.5 degrees C)
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. Christian Hinrichs
Organization: National Cancer Institute
Phone: 301-435-3027
Responsible Party: Christian S. Hinrichs, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02280811     History of Changes
Other Study ID Numbers: 150005
15-C-0005
First Submitted: October 30, 2014
First Posted: November 3, 2014
Results First Submitted: June 8, 2017
Results First Posted: August 2, 2017
Last Update Posted: September 6, 2017