Cell Therapy for Metastatic Melanoma Using CD8 Enriched Tumor Infiltrating Lymphocytes

This study has been terminated.
(Unexpected toxicities, likely due to TIL/IL-12 & low % of durable responses.)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01236573
First received: November 5, 2010
Last updated: October 26, 2015
Last verified: October 2015
Results First Received: August 20, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Skin Cancer
Metastatic Melanoma
Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Biological: IL-12 transduced TIL

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)

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.

Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)

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.

Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)

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.

Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)

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.

Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)

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.

Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)

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.

Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)

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.

Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)

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.

Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)

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.

Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)

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.

Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)

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.


Participant Flow for 3 periods

Period 1:   Phase 1-Dose Escalation-Cohorts 1-4
    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)  
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 2:   Phase 1-Dose Escalation-Cohorts 5-10
    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)  
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  
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 3:   Phase 2- MTD/Anti-IL-12 Cells-Cohort 11
    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)  
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  
Did not receive cells                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)

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.

Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)

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.

Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)

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.

Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)

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.

Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)

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.

Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)

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.

Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)

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.

Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)

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.

Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)

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.

Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)

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.

Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)

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 Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
  1     1     6     1     1     4     3     3     4     4     6     34  
Age  
[units: participants]
                       
<=18 years     0     0     0     0     0     0     0     0     0     0     0     0  
Between 18 and 65 years     1     1     6     1     1     4     3     3     3     3     5     31  
>=65 years     0     0     0     0     0     0     0     0     1     1     1     3  
Age  
[units: years]
Mean (Standard Deviation)
  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)  
Gender  
[units: participants]
                       
Female     1     0     1     0     0     1     2     1     1     2     0     9  
Male     0     1     5     1     1     3     1     2     3     2     6     25  
Ethnicity (NIH/OMB)  
[units: participants]
                       
Hispanic or Latino     0     0     0     0     0     0     0     1     0     1     0     2  
Not Hispanic or Latino     1     1     6     1     1     4     3     2     4     3     6     32  
Unknown or Not Reported     0     0     0     0     0     0     0     0     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
                       
American Indian or Alaska Native     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  
Native Hawaiian or Other Pacific Islander     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  
White     1     1     6     1     1     4     3     3     4     3     6     33  
More than one race     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     1     0     1  
Region of Enrollment  
[units: participants]
                       
United States     1     1     6     1     1     4     3     3     4     4     6     34  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: 4 years ]

2.  Primary:   Response (Complete Response (CR) + Partial Response (PR)) to Therapy   [ Time Frame: 4 years ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 49 months and 20 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: sar@mail.nih.gov


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

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
Study First Received: November 5, 2010
Results First Received: August 20, 2015
Last Updated: October 26, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration