NCT00006385CompletedPhase 2
Phase II Evaluation of Immunization With an HLA-A2 Multi-Epitope Peptide Vaccine Containing MART-1 (NSC #672643), gp100 (NSC #683472), and Tyrosinase (NSC #699048) Peptides Alone or in Combination With GM-CSF, IFN Alpha-2b, or GM-CSF + IFN Alpha-2b in Patients With Metastatic Melanoma
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Locations
- 32
Study Overview
Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as sargramostim and interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if vaccine therapy if more effective with or without biological therapy for melanoma.
PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or without biological therapy in treating patients who have metastatic melanoma.
Detailed Description
OBJECTIVES:
- Determine immune response of vaccination with melanoma associated antigens (MART-1:27-35, gp100:209-217 (210M), and tyrosinase:368-376 (370D)) on the number of peptide specific CD8+ T-cell precursors in HLA-A2 positive patients with metastatic melanoma.
- Determine the influence of sargramostim (GM-CSF) and/or interferon alfa-2b (IFN-A) on the immune responses of these patients and toxicity of this melanoma peptide vaccine.
- Determine any antitumor and anti-pigmentary response that may result from immunization against MART-1, gp100 and tyrosinase peptides, and determine the relationship between such clinical observations and immune responses against lineage antigens with or without GM-CSF and/or IFN-A.
- Compare the relapse free survival and overall survival of patients treated with melanoma peptide vaccine alone or in combination with GM-CSF and/or IFN-A.
OUTLINE: This is a randomized, multicenter study.
Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive multiepitope peptide (MEP) vaccine comprising MART-1:27-35, gp100:209-217 (210M), and tyrosinase:368-376 (370D) peptides. Each peptide is separately emulsified in Montanide ISA-51 and administered subcutaneously (SC) (for a total of 2 injections per peptide) on days 1 and 15.
- Arm II: Patients receive MEP vaccine as in arm I and sargramostim (GM-CSF) subcutaneously (SC) daily on days 1-14.
- Arm III: Patients receive MEP vaccine as in arm I and interferon alfa-2b SC three times a week.
- Arm IV: Patients receive MEP vaccine as in arm I, GM-CSF as in arm II, and interferon alfa-2b as in arm III.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically proven stage IV melanoma
- •Measurable disease
- •At least 1 lesion must be a minimum of 1.0 cm in diameter
- •Bone metastases are not considered to be measurable disease
- •No prior radiotherapy to area of measurable disease unless there is clearly progressive disease in this site or measurable disease exists outside the area of prior radiotherapy
- •HLA-A2 positive
- •No brain disease by MRI or CT scan within 4 weeks prior to randomization
- •Prior brain disease allowed if no evidence of active disease by 2 successive MRI evaluations completed at least 3 months apart
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Lymphocyte count greater than 700/mm ^3
- •SGOT no greater than 2 times upper limit of normal (ULN)
- •Bilirubin no greater than 2 times ULN
- •Alkaline phosphatase and lactic dehydrogenase no greater than 2 times ULN
- •Creatinine no greater than 1.8 mg/dL
- •No significant detectable infection
- •HIV negative
- •No other malignancy within the past 5 years except:
- •Any carcinoma in situ
- •Lobular carcinoma in situ of the breast
- •Carcinoma in situ of the cervix
- •Atypical melanocytic hyperplasia
- •Melanoma in situ
- •Basal cell or squamous cell skin cancer
- •No autoimmune disorders or conditions of immunosuppression
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior MART-1:27-35, gp100:209-217 (210M), or tyrosinase:368-376 (370D) peptide
- •Greater than 4 weeks since prior adjuvant immunotherapy, including sargramostim (GM-CSF) or interferon alfa-2b
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •Endocrine therapy:
- •At least 2 weeks since prior and no concurrent systemic corticosteroids, including oral steroids (i.e., prednisone, dexamethasone); continuous use of topical steroid creams or ointments; or any inhalers containing steroids
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy for local control or palliation and recovered
- •Recovered from any prior major surgery
Exclusion Criteria
- Not provided
Investigators
Study Sites (32)
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