Vaccine Therapy Plus Immune Adjuvants in Treating Patients With Advanced Melanoma
|ClinicalTrials.gov Identifier: NCT00003362|
Recruitment Status : Completed
First Posted : August 26, 2004
Last Update Posted : June 25, 2013
RATIONALE: Vaccines made from peptides that are found on melanoma cells may make the body build an immune response and kill melanoma cells. Combining vaccine therapy with immune adjuvants, such as GM-CSF, Montanide ISA-51, or QS21, may be a more effective treatment for advanced melanoma.
PURPOSE: Randomized phase II trial to study the effectiveness of gp 100-tyrosinase peptide vaccine with one of the immune adjuvants GM-CSF, Montanide ISA-51, or QS21 in treating patients who have stage III or stage IV melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: QS21 Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: sargramostim Biological: tyrosinase peptide||Phase 2|
OBJECTIVES: I. Evaluate the immunogenicity of gp100-tyrosinase peptide vaccine with sargramostim (GM-CSF), Montanide ISA-51, or QS21 as adjuvant in patients with advanced melanoma. II. Determine the toxicity of this multiepitope melanoma peptide vaccine in conjunction with these 3 adjuvants in these patients. III. Evaluate the antitumor effects of this multiepitope melanoma peptide vaccine in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to age (65 years and under vs more than 65 years) and previous systemic chemotherapy (yes vs no). Patients are randomized to 1 of 3 treatment arms: Arm I (Sargramostim (GM-CSF) as adjuvant): Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine administered intradermally during weeks 1, 5, and 9. For each vaccination, GM-CSF is administered intradermally on days 1-10; the vaccine is administered on day 7. Arm II (Montanide ISA-51): Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine mixed with Montanide ISA-51 and administered subcutaneously (SQ) during weeks 1, 5, and 9. Arm III (QS21 as adjuvant): Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine mixed with QS21 and administered SQ during weeks 1, 5, and 9. Patients with stable or responding disease may receive 3 additional monthly immunizations beginning 3-6 months following completion of 1 course of immunizations if there is evidence of T cell response against either wild type peptide. Patients are followed at weeks 13 and 17.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 18-24 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Pilot Trial of Multi-Epitope Melanoma Peptide Vaccine Using GM-CSF, Montanide and QS-21 as Adjuvants|
|Study Start Date :||May 1998|
|Primary Completion Date :||February 2001|
|Study Completion Date :||February 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003362
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Paul B. Chapman, MD||Memorial Sloan Kettering Cancer Center|