Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
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|ClinicalTrials.gov Identifier: NCT00005949|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Melanoma Stage IV Melanoma||Biological: aldesleukin Biological: gp100:209-217(210M) peptide vaccine Other: laboratory biomarker analysis||Phase 2|
I. Determine clinical response rates in patients with advanced melanoma treated with gp100:209-217(210M) melanoma vaccine and low-dose interleukin-2.
II. Assess response duration and progression-free intervals in these patients receiving this treatment.
Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 subcutaneously (SC) on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 3 additional courses after achieving CR.
Patients are followed every 9 weeks for 3 years or until disease recurrence.
PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma|
|Study Start Date :||March 2001|
|Actual Primary Completion Date :||March 2006|
Experimental: Treatment (gp100:209-217, aldesleukin )
Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 SC on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a CR receive 3 additional courses after achieving CR.
Biological: gp100:209-217(210M) peptide vaccine
Other: laboratory biomarker analysis
- Clinical response rate (CR or PR) [ Time Frame: From the start of treatment until disease progression/recurrence, assessed up to 3 years ]
- Response duration [ Time Frame: Up to 3 years ]The Kaplan-Meier method will be used to estimate duration of response.
- Progression-free intervals [ Time Frame: Up to 3 years ]The Kaplan-Meier method will be used to estimate time to progression.
- Immunologic response rate using ELISPOT assay [ Time Frame: Up to 3 years ]Described in terms of frequency and kinetics. Agreement between clinical and immunological response will be measured using the kappa coefficient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005949
|United States, Illinois|
|Cancer and Leukemia Group B|
|Chicago, Illinois, United States, 60606|
|Principal Investigator:||John Roberts||Cancer and Leukemia Group B|