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Trial record 16 of 283 for:    Tumor infiltrating lymphocytes

Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT01468818
Recruitment Status : Terminated (Study was closed prematurely due to slow and insufficient accrual.)
First Posted : November 10, 2011
Results First Posted : June 27, 2016
Last Update Posted : June 27, 2016
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 Metastatic Melanoma
Skin Cancer
Interventions Drug: Cyclophosphamide
Drug: Fludarabine
Biological: Young Tumor Infiltrating Lymphocytes (TIL)
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Immunotherapy for Metastatic Melanoma
Hide Arm/Group Description

Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.

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

Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).

Period Title: Overall Study
Started 18
Completed 16
Not Completed 2
Reason Not Completed
Death during treatment             2
Arm/Group Title Immunotherapy for Metastatic Melanoma
Hide Arm/Group Description

Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.

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

Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  77.8%
>=65 years
4
  22.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
56.8  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
8
  44.4%
Male
10
  55.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
18
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 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
18
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Objective Response in Patients With Metastatic Melanoma
Hide Description Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). 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 of the 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 references the smallest sum LD.
Time Frame Approximately 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunotherapy for Metastatic Melanoma
Hide Arm/Group Description:

Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.

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

Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
Not Evaluable 1
Progressive Disease 12
Partial Response 5
2.Secondary Outcome
Title Level of Persistence of the Transferred Cells in Blood
Hide Description Determine level of transferred cells in the blood following a non-myeloablative lymphodepleting chemotherapy preparative regimen.
Time Frame Once week and one month after transfer
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected or analyzed, thus we did not perform an evaluation of persistence for this trial. The reason is that we did not accrue a sufficient number of patients in a timely manner. A minimum of 35 subjects was needed to perform an analysis.
Arm/Group Title Immunotherapy for Metastatic Melanoma
Hide Arm/Group Description:

Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.

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

Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immunotherapy for Metastatic Melanoma
Hide Arm/Group Description

Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.

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

Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).

All-Cause Mortality
Immunotherapy for Metastatic Melanoma
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Immunotherapy for Metastatic Melanoma
Affected / at Risk (%) # Events
Total   1/18 (5.56%)    
General disorders   
Death not associated with CTCAE term  1  1/18 (5.56%)  1
Infections and infestations   
Infection  1  1/18 (5.56%)  1
Metabolism and nutrition disorders   
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Adult Respiratory Distress Syndrome (ARDS)  1  1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Immunotherapy for Metastatic Melanoma
Affected / at Risk (%) # Events
Total   18/18 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  6/18 (33.33%)  6
Leukocytes (total WBC)  1  18/18 (100.00%)  18
Lymphopenia  1  18/18 (100.00%)  18
Neutrophils/granulocytes (ANC/AGC)  1  18/18 (100.00%)  18
Platelets  1  15/18 (83.33%)  15
Cardiac disorders   
Supraventricular and nodal arrhythmia  1  1/18 (5.56%)  1
Hypotension  1  1/18 (5.56%)  1
Gastrointestinal disorders   
Constipation  1  2/18 (11.11%)  2
Diarrhea  1  2/18 (11.11%)  2
Nausea  1  1/18 (5.56%)  1
General disorders   
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)  1  1/18 (5.56%)  1
Rigors/chills  1  2/18 (11.11%)  2
Weight gain  1  1/18 (5.56%)  1
Pain  1  5/18 (27.78%)  5
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  1/18 (5.56%)  1
Infections and infestations   
Colitis, infectious (e.g., Clostridium difficile)  1  1/18 (5.56%)  1
Febrile neutropenia  1 [1]  11/18 (61.11%)  11
Infection  1  6/18 (33.33%)  6
Metabolism and nutrition disorders   
ALT/SGPT (serum glutamic pyruvic transaminase)  1  2/18 (11.11%)  2
Albumin, serum-low (hypoalbuminemia)  1  2/18 (11.11%)  2
Alkaline phosphatase  1  1/18 (5.56%)  1
Potassium, serum-low (hypokalemia)  1  1/18 (5.56%)  1
Sodium, serum-low (hyponatremia)  1  1/18 (5.56%)  1
Nervous system disorders   
Psychosis (hallucinations/delusions)  1  1/18 (5.56%)  1
Renal and urinary disorders   
Incontinence, urinary  1  1/18 (5.56%)  1
Renal/Genitourinary - Other (Oliguria)  1  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  2/18 (11.11%)  2
Hypoxia  1  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders   
Pruritis/itching  1  1/18 (5.56%)  1
Vascular disorders   
Thrombosis/embolism (vascular access-related)  1  1/18 (5.56%)  1
Thrombosis/thrombus/embolism  1  1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0x10e9/L, fever >38.5 degrees C)
Study was closed prematurely due to slow and insufficient accrual.
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: NCT01468818     History of Changes
Other Study ID Numbers: 110260
11-C-0260
First Submitted: October 6, 2011
First Posted: November 10, 2011
Results First Submitted: May 19, 2016
Results First Posted: June 27, 2016
Last Update Posted: June 27, 2016