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Trial record 21 of 283 for:    Tumor infiltrating lymphocytes

Modified Tumor Infiltrating Lymphocytes for Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT01369875
Recruitment Status : Completed
First Posted : June 9, 2011
Results First Posted : March 21, 2013
Last Update Posted : October 28, 2015
Sponsor:
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: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Melanoma
Skin Cancer
Interventions Drug: Cyclophosphamide
Drug: Fludarabine
Biological: Aldesleukin
Biological: Tumor Infiltrating Lymphocytes
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Young TIL ECCE Young TIL
Hide Arm/Group Description

Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0

Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)

Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)

Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6

Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0

Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)

Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)

Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6

Period Title: Overall Study
Started 1 1
Completed 1 1
Not Completed 0 0
Arm/Group Title Standard Young TIL ECCE Young TIL Total
Hide Arm/Group Description

Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0

Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)

Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)

Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6

Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0

Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)

Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)

Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6

Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
2
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 2 participants
50.0 46.0 48.0  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
1
 100.0%
1
 100.0%
2
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
1
 100.0%
1
 100.0%
2
 100.0%
Unknown or Not Reported
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 2 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
 100.0%
1
  50.0%
White
1
 100.0%
0
   0.0%
1
  50.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1 1 2
1.Primary Outcome
Title Clinical Tumor Regression.
Hide Description Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a 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. Progression (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 new lesions.Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Young TIL ECCE Young TIL
Hide Arm/Group Description:

Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0

Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)

Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)

Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6

Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0

Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)

Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)

Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: Participants
Complete Response 0 0
Partial Response 0 0
Progression 1 1
Stable Disease 0 0
2.Secondary Outcome
Title Toxicity
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 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Young TIL ECCE Young TIL
Hide Arm/Group Description:

Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0

Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)

Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)

Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6

Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0

Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)

Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)

Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: Participants
1 1
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Young TIL ECCE Young TIL
Hide Arm/Group Description

Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0

Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)

Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)

Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6

Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0

Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)

Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)

Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6

All-Cause Mortality
Standard Young TIL ECCE Young TIL
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Standard Young TIL ECCE Young TIL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Young TIL ECCE Young TIL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/1 (100.00%)    
Blood and lymphatic system disorders     
Hemoglobin  1  1/1 (100.00%)  1 1/1 (100.00%)  1
Leukocytes (total WBC)  1  1/1 (100.00%)  1 1/1 (100.00%)  1
Lymphopenia  1  1/1 (100.00%)  1 1/1 (100.00%)  1
Neutrophils/granulocytes (ANC/AGC)  1  1/1 (100.00%)  1 1/1 (100.00%)  1
Platelets  1  1/1 (100.00%)  1 1/1 (100.00%)  1
General disorders     
Fatigue (asthenia, lethargy, malaise)  1  1/1 (100.00%)  1 1/1 (100.00%)  1
Pain  1  0/1 (0.00%)  0 1/1 (100.00%)  1
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  0/1 (0.00%)  0 1/1 (100.00%)  1
Infections and infestations     
Febrile neutropenia  1 [1]  1/1 (100.00%)  1 1/1 (100.00%)  1
Nervous system disorders     
Neuropathy: motor  1  0/1 (0.00%)  0 1/1 (100.00%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea (shortness of breath)  1  1/1 (100.00%)  1 0/1 (0.00%)  0
Hypoxia  1  1/1 (100.00%)  1 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders     
Hypopigmentation  1  1/1 (100.00%)  1 0/1 (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 <1.0 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. Steven Rosenberg
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
Responsible Party: Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01369875     History of Changes
Other Study ID Numbers: 110163
11-C-0163
First Submitted: June 8, 2011
First Posted: June 9, 2011
Results First Submitted: February 14, 2013
Results First Posted: March 21, 2013
Last Update Posted: October 28, 2015