Pilot Trial of Multi-Epitope Melanoma Peptide Vaccine Using GM-CSF, Montanide and QS-21 as Adjuvants
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
Pilot Trial of Multi-Epitope Melanoma Peptide Vaccine Using GM-CSF, Montanide and QS-21 as Adjuvants
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed unresectable stage III or stage IV
melanoma Patients who are disease free following surgical resection or chemotherapy for
stage III or IV disease also eligible HLA-A201 positive
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: At least 5 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at
least 75,000/mm3 LDH no greater than 2 times upper limit of normal No active bleeding
Hepatic: Albumin at least 3.5 mg/dL Renal: Not specified Other: Not pregnant or less than
3 months postpartum Fertile patients must use effective contraception No serious
underlying medical conditions No known immunodeficiency No active infection No retinal or
choroidal eye disease
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and
recovered No prior tyrosinase or gp100 peptides No prior Montanide ISA-51 No prior
melanoma protein vaccine or melanoma whole cell vaccines No other concurrent immunotherapy
Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent
chemotherapy Endocrine therapy: At least 2 weeks since prior systemic steroids and
recovered No concurrent systemic steroids Radiotherapy: At least 4 weeks since prior
radiotherapy and recovered No prior radiotherapy to the spleen No concurrent radiotherapy
Surgery: Recovered from any prior surgery No prior splenectomy Other: At least 1 week
since prior antiinflammatory drugs and recovered At least 1 week since prior
antihistamines and recovered No concurrent antiinflammatory drugs No concurrent
antihistamines No concurrent antimicrobial drugs
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Paul B. Chapman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
98-012
NCT ID:
NCT00003362
Start Date:
May 1998
Completion Date:
February 2001
Related Keywords:
- Melanoma (Skin)
- stage III melanoma
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
