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Chemotherapy Followed by gp100 Lymphocytes and Aldesleukin to Treat Melanoma

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ClinicalTrials.gov Identifier: NCT00665470
Recruitment Status : Completed
First Posted : April 24, 2008
Results First Posted : January 22, 2013
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Udai Kammula, 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 Skin Cancer
Metastatic Melanoma
Intervention Drug: Aldesleukin
Enrollment 10
Recruitment Details  
Pre-assignment Details All patients were enrolled into cohort I because all patients were able to receive high dose IL-2.
Arm/Group Title Cohort I - High Dose Aldesleukin Cohort II - Low Dose Aldesleukin
Hide Arm/Group Description Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses). Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
Period Title: Overall Study
Started 10 0
Completed 10 0
Not Completed 0 0
Arm/Group Title Cohort I - High Dose Aldesleukin Cohort II - Low Dose Aldesleukin Total
Hide Arm/Group Description Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses). Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 10 0 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 0 participants 10 participants
<=18 years 0 0
Between 18 and 65 years 9 9
>=65 years 1 1
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 0 participants 10 participants
54.36  (9.23) 54.36  (9.23)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 0 participants 10 participants
Female 2 2
Male 8 8
Ethnicity (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 0 participants 10 participants
Hispanic or Latino 0 0
Not Hispanic or Latino 10 10
Unknown or Not Reported 0 0
Race (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 0 participants 10 participants
American Indian or Alaska Native 0 0
Asian 0 0
Native Hawaiian or Other Pacific Islander 0 0
Black or African American 1 1
White 9 9
More than one race 0 0
Unknown or Not Reported 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 0 participants 10 participants
10 10
1.Primary Outcome
Title Response
Hide Description Response is 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 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 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort I - High Dose Aldesleukin Cohort II - Low Dose Aldesleukin
Hide Arm/Group Description:
Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
Overall Number of Participants Analyzed 10 0
Measure Type: Number
Unit of Measure: Participants
Complete Response 0
Partial Response 0
Progression 8
Stable Disease 2
2.Primary Outcome
Title Toxicity as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V3.0
Hide Description Here is the number of participants with adverse events. For a detailed list of participants with adverse events, see the adverse event module.
Time Frame 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort I - High Dose Aldesleukin Cohort II - Low Dose Aldesleukin
Hide Arm/Group Description:
Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
Overall Number of Participants Analyzed 10 0
Measure Type: Number
Unit of Measure: Participants
10
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort I - High Dose Aldesleukin Cohort II - Low Dose Aldesleukin
Hide Arm/Group Description Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses). Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
All-Cause Mortality
Cohort I - High Dose Aldesleukin Cohort II - Low Dose Aldesleukin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort I - High Dose Aldesleukin Cohort II - Low Dose Aldesleukin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/10 (30.00%)      0/0    
Gastrointestinal disorders     
Diarrhea  1  1/10 (10.00%)  1 0/0  0
Vomiting  1  1/10 (10.00%)  1 0/0  0
General disorders     
Esophagitis  1  1/10 (10.00%)  1 0/0  0
Vascular disorders     
Thromboembolic event  1  1/10 (10.00%)  1 0/0  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort I - High Dose Aldesleukin Cohort II - Low Dose Aldesleukin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      0/0    
Blood and lymphatic system disorders     
Anemia  1  4/10 (40.00%)  5 0/0  0
Neutrophil count decreased  1  10/10 (100.00%)  11 0/0  0
Platelet count decreased  1  10/10 (100.00%)  11 0/0  0
White blood cell decreased  1  10/10 (100.00%)  11 0/0  0
Cardiac disorders     
Hypotension  1  1/10 (10.00%)  1 0/0  0
Ear and labyrinth disorders     
Hearing impaired  1  1/10 (10.00%)  1 0/0  0
Gastrointestinal disorders     
Nausea  1  1/10 (10.00%)  1 0/0  0
General disorders     
Fatigue  1  5/10 (50.00%)  5 0/0  0
Fever  1  1/10 (10.00%)  1 0/0  0
Infections and infestations     
Febrile neutropenia  1  5/10 (50.00%)  6 0/0  0
Infections and infestations - Other, infection: klebsiella pneumoniae  1  1/10 (10.00%)  1 0/0  0
Investigations     
Activated partial thromboplastin time prolonged  1  3/10 (30.00%)  3 0/0  0
Lymphocyte count decreased  1  10/10 (100.00%)  12 0/0  0
Metabolism and nutrition disorders     
Creatinine increased  1  1/10 (10.00%)  1 0/0  0
Hypermagnesemia  1  1/10 (10.00%)  1 0/0  0
Hypophosphatemia  1  2/10 (20.00%)  2 0/0  0
Nervous system disorders     
Cognitive disturbance  1  1/10 (10.00%)  1 0/0  0
Confusion  1  2/10 (20.00%)  2 0/0  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  3/10 (30.00%)  3 0/0  0
Hypoxia  1  1/10 (10.00%)  1 0/0  0
Rash maculo-papular  1  6/10 (60.00%)  6 0/0  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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: Dr. Steven Rosenberg
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
EMail: sar@mail.nih.gov
Layout table for additonal information
Responsible Party: Udai Kammula, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00665470     History of Changes
Other Study ID Numbers: 080104
08-C-0104
First Submitted: April 23, 2008
First Posted: April 24, 2008
Results First Submitted: December 12, 2012
Results First Posted: January 22, 2013
Last Update Posted: October 19, 2015