Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
|Recurrent Melanoma Stage IV Melanoma||Biological: aldesleukin Biological: gp100:209-217(210M) peptide vaccine Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma|
- 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.
|Study Start Date:||March 2001|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
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.
Other Names:Biological: gp100:209-217(210M) peptide vaccine
Other Names:Other: laboratory biomarker analysis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005949
|United States, Illinois|
|Cancer and Leukemia Group B|
|Chicago, Illinois, United States, 60606|
|Principal Investigator:||John Roberts||Cancer and Leukemia Group B|