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Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT00096382
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : March 27, 2013
Last Update Posted : October 28, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma (Skin)
Interventions Biological: aldesleukin
Biological: filgrastim
Biological: therapeutic tumor infiltrating lymphocytes
Drug: cyclophosphamide
Drug: fludarabine phosphate
Radiation: radiation therapy
Enrollment 34
Recruitment Details  
Pre-assignment Details Of the 34 participants who were enrolled, 8 patients were not assigned to treatment since their TIL did not grow. Of the 26 assigned to treatment, 1 patient was not actually treated therefore only 25 patients were evaluable.
Arm/Group Title TBI 200cGy + TIL +HD IL-2, Prior IL-2 TBI 200cGy + TIL +HD IL-2, No Prior IL-2
Hide Arm/Group Description

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.

Period Title: Overall Study
Started 23 3
Completed 21 3
Not Completed 2 0
Reason Not Completed
Not treated             1             0
Death during treatment             1             0
Arm/Group Title TBI 200cGy + TIL +HD IL-2, Prior IL-2 TBI 200cGy + TIL +HD IL-2, No Prior IL-2 Total
Hide Arm/Group Description

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.

Total of all reporting groups
Overall Number of Baseline Participants 23 3 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 3 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
3
 100.0%
26
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 3 participants 26 participants
43.9  (9.6) 48.3  (12.0) 44.4  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 3 participants 26 participants
Female
8
  34.8%
0
   0.0%
8
  30.8%
Male
15
  65.2%
3
 100.0%
18
  69.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 3 participants 26 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
23
 100.0%
3
 100.0%
26
 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 23 participants 3 participants 26 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%
0
   0.0%
0
   0.0%
White
23
 100.0%
3
 100.0%
26
 100.0%
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 23 participants 3 participants 26 participants
23 3 26
1.Primary Outcome
Title Clinical Tumor Regression
Hide Description Tumor regression is defined as a complete response (CR) or partial response (PR) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the 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 Every 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TBI 200cGy + TIL +HD IL-2, Prior IL-2 TBI 200cGy + TIL +HD IL-2, No Prior IL-2
Hide Arm/Group Description:

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.

Overall Number of Participants Analyzed 23 3
Measure Type: Number
Unit of Measure: Participants
Complete Response 1 1
Partial Response 9 2
2.Primary Outcome
Title Safety
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 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TBI 200cGy + TIL +HD IL-2, Prior IL-2 TBI 200cGy + TIL +HD IL-2, No Prior IL-2
Hide Arm/Group Description:

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.

Overall Number of Participants Analyzed 23 3
Measure Type: Number
Unit of Measure: Participants
23 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TBI 200cGy + TIL +HD IL-2, Prior IL-2 TBI 200cGy + TIL +HD IL-2, No Prior IL-2
Hide Arm/Group Description

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.

All-Cause Mortality
TBI 200cGy + TIL +HD IL-2, Prior IL-2 TBI 200cGy + TIL +HD IL-2, No Prior IL-2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
TBI 200cGy + TIL +HD IL-2, Prior IL-2 TBI 200cGy + TIL +HD IL-2, No Prior IL-2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/22 (13.64%)      1/3 (33.33%)    
Gastrointestinal disorders     
Dehydration  1  1/22 (4.55%)  1 0/3 (0.00%)  0
General disorders     
Fatigue  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Infections and infestations     
Infection  1  3/22 (13.64%)  3 0/3 (0.00%)  0
Nervous system disorders     
Somnolence/depressed level of consciousness  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Hypoxia  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Pneumonitis  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Vascular disorders     
Thrombosis  1  0/22 (0.00%)  0 1/3 (33.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv3.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TBI 200cGy + TIL +HD IL-2, Prior IL-2 TBI 200cGy + TIL +HD IL-2, No Prior IL-2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/22 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders     
Hemoglobin  1  6/22 (27.27%)  6 1/3 (33.33%)  1
Leukocytes (total WBC)  1  17/22 (77.27%)  17 1/3 (33.33%)  1
Neutrophils/granulocytes (ANC/AGC)  1  21/22 (95.45%)  21 3/3 (100.00%)  3
Platelet  1  16/22 (72.73%)  16 3/3 (100.00%)  3
Edema: head and neck  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Lymphopenia  1  22/22 (100.00%)  22 3/3 (100.00%)  3
PTT (partial thromboplastin time)  1  3/22 (13.64%)  3 3/3 (100.00%)  3
Cardiac disorders     
Ventricular arrhythmia  1  1/22 (4.55%)  1 3/3 (100.00%)  3
Supraventricular & nodal arrhythmia  1  1/22 (4.55%)  1 3/3 (100.00%)  3
Vasovagal episode  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Hypertension  1  1/22 (4.55%)  1 1/3 (33.33%)  1
Hypotension  1  8/22 (36.36%)  8 0/3 (0.00%)  0
Eye disorders     
Retinopathy  1  0/22 (0.00%)  0 1/3 (33.33%)  1
Gastrointestinal disorders     
Diarrhea  1  4/22 (18.18%)  4 1/3 (33.33%)  1
Distention, bloating, abdominal  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Heartburn/Dyspepsia  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Nausea  1  2/22 (9.09%)  2 0/3 (0.00%)  0
Vomiting  1  3/22 (13.64%)  3 0/3 (0.00%)  0
Hemorrhage, GI  1  1/22 (4.55%)  1 0/3 (0.00%)  0
General disorders     
Rigors/Chills  1  2/22 (9.09%)  2 0/3 (0.00%)  0
Fatigue (asthenia, lethargy, malaise)  1  4/22 (18.18%)  4 0/3 (0.00%)  0
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  3/22 (13.64%)  3 2/3 (66.67%)  2
Insomnia  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Weight loss  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Pain  1  11/22 (50.00%)  11 0/3 (0.00%)  0
Infections and infestations     
Febrile Neutropenia  1 [1]  9/22 (40.91%)  9 3/3 (100.00%)  3
Infection  1  5/22 (22.73%)  5 0/3 (0.00%)  0
Metabolism and nutrition disorders     
Albumin, serum-low (hypoalbuminemia)  1  9/22 (40.91%)  9 1/3 (33.33%)  1
ALT/SGPT (serum glutamic pyruvic transaminase)  1  2/22 (9.09%)  2 0/3 (0.00%)  0
AST/SGOT (serum glutamic oxaloacetic transaminase)  1  2/22 (9.09%)  2 0/3 (0.00%)  0
Bilirubin (hyperbilirubinemia)  1  2/22 (9.09%)  2 1/3 (33.33%)  1
Calcium, serum-low (hypocalcemia)  1  4/22 (18.18%)  4 1/3 (33.33%)  2
Creatinine  1  3/22 (13.64%)  3 0/3 (0.00%)  0
Magnesium, serum-high (hypermagnesemia)  1  2/22 (9.09%)  2 1/3 (33.33%)  1
Magnesium, serum-low (hypomagnesemia)  1  1/22 (4.55%)  1 1/3 (33.33%)  1
Phosphate, serum-low (hypophosphatemia)  1  3/22 (13.64%)  3 1/3 (33.33%)  2
Potassium, serum-high (hyperkalemia) increased  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Potassium, serum-low (hypokalemia)  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Sodium, serum-low (hyponatremia)  1  3/22 (13.64%)  3 1/3 (33.33%)  1
Uric acid  1  3/22 (13.64%)  3 0/3 (0.00%)  0
Nervous system disorders     
Apnea  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Leak, Cerebrospinal fluid (CSF)  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Confusion  1  3/22 (13.64%)  3 1/3 (33.33%)  1
Dizziness  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Somnolence/depressed level of consciousness  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Syncope (fainting)  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Tremor  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Mood alteration  1  0/22 (0.00%)  0 1/3 (33.33%)  1
Renal and urinary disorders     
Incontinence, urinary  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Renal failure  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hemorrhage, pulmonary/upper respiratory  1  2/22 (9.09%)  2 0/3 (0.00%)  0
Atelectasis  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Cough  1  2/22 (9.09%)  2 0/3 (0.00%)  0
Dyspnea (shortness of breath)  1  13/22 (59.09%)  13 2/3 (66.67%)  2
Hypoxia  1  5/22 (22.73%)  5 1/3 (33.33%)  1
Pneumonitis/pulmonary infiltrates  1  1/22 (4.55%)  1 1/3 (33.33%)  1
Skin and subcutaneous tissue disorders     
Hypopigmentation  1  2/22 (9.09%)  2 1/3 (33.33%)  1
Rash/Desquamation  1  2/22 (9.09%)  2 0/3 (0.00%)  0
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Vascular disorders     
Acute vascular leak syndrome  1  1/22 (4.55%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv3.0
[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
Layout table for Results Point of Contact information
Name/Title: Steven A. Rosenberg, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
EMail: sar@mail.nih.gov
Layout table for additonal information
Responsible Party: Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00096382    
Obsolete Identifiers: NCT00092248
Other Study ID Numbers: 040288
04-C-0288
NCI-7025
NCI-PRMC-P6273
CDR0000393480
First Submitted: November 9, 2004
First Posted: November 9, 2004
Results First Submitted: November 20, 2012
Results First Posted: March 27, 2013
Last Update Posted: October 28, 2015