Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
Status and phase
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Treatments
Details and patient eligibility
About
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining vaccine therapy with a monoclonal antibody may cause a stronger immune response and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with monoclonal antibody therapy in treating patients who have stage IV melanoma.
Full description
OBJECTIVES:
- Determine the clinical response in patients with stage IV melanoma when treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51.
- Determine a safety and adverse event profile of this regimen in these patients.
- Determine improved immunologic response in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes immediately followed by gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51 subcutaneously on days 1, 22, 43, and 64. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study within 2 years.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed stage IV melanoma
- Mucosal or ocular melanoma allowed
-
Clinically evaluable disease
-
HLA-A*0201 positive
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 6 months
Hematopoietic:
- WBC at least 2,500/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
- Hematocrit at least 30%
Hepatic:
- AST no greater than 3 times upper limit of normal (ULN)
- Bilirubin no greater than ULN (less than 3.0 mg/dL in patients with Gilbert's syndrome)
- Hepatitis B surface antigen negative
- Hepatitis C antibody nonreactive
Renal:
- Creatinine less than 2.0 mg/dL
Immunologic:
- Antinuclear antibody negative
- Thyroglobulin antibody normal
- Rheumatoid factor normal
- HIV negative
- No prior autoimmune disease (including uveitis and autoimmune inflammatory eye disease)
- No active infection
- No hypersensitivity to Montanide ISA-51
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- No other underlying medical condition that would preclude study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 3 weeks since prior immunotherapy for melanoma and recovered
- No prior gp100 peptides
- No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
Chemotherapy:
- At least 3 weeks since prior chemotherapy for melanoma and recovered
- No concurrent chemotherapy
Endocrine therapy:
- At least 3 weeks since prior hormonal therapy for melanoma and recovered
- At least 4 weeks since prior systemic or topical corticosteroids
- No concurrent topical or systemic corticosteroids
Radiotherapy:
- At least 3 weeks since prior radiotherapy for melanoma and recovered
Surgery:
- Not specified
Other:
- No other concurrent immunosuppressive agents (e.g., cyclosporine and its analog)
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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