Status:
COMPLETED
Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Intraocular Melanoma
Melanoma (Skin)
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines may make the body build an immune respon...
Detailed Description
OBJECTIVES: Primary * Achieve at least a 40% autoimmune breakthrough event rate, as defined by the induction of grade 1, grade 2, or acceptable grade 3 drug-related autoimmune adverse events, in pat...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed melanoma
- Stage III (≥ 3 positive lymph nodes) or stage IV disease
- Mucosal or ocular melanoma allowed
- Completely resected within the past 6 months
- Patients with stage III resected melanoma rendered free of disease may have failed, been ineligible for, or refused prior treatment with interferon alfa
- Positive staining of tumor tissue for at least one of the following:
- Antibody HMB-45 for gp100
- Antibody HMB-45 for tyrosinase
- Antibody HMB-45 for MART-1
- HLA-A\*0201 positive by DNA allele-specific polymerase chain reaction assay
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-1
- Life expectancy
- At least 6 months
- Hematopoietic
- WBC ≥ 2,500/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hematocrit ≥ 30%
- Hemoglobin ≥ 10 g/dL
- Hepatic
- AST ≤ 3 times upper limit of normal (ULN)\*
- Bilirubin ≤ ULN\* (\< 3.0 mg/dL for patients with Gilbert's syndrome)
- No significant hepatic disease that would preclude study participation
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative NOTE: \* Unless attributable to disease
- Renal
- Creatinine ≤ 2.0 mg/dL
- No significant renal disease that would preclude study participation
- Cardiovascular
- No significant cardiac disease that would preclude study participation
- Pulmonary
- No significant pulmonary disease that would preclude study participation
- Immunologic
- No history of any of the following:
- Inflammatory bowel disease or any other autoimmune bowel disease
- Systemic lupus erythematosus
- Rheumatoid arthritis
- Autoimmune ocular disease
- No systemic hypersensitivity to Montanide ISA-51 or any vaccine component
- No active infection requiring therapy
- HIV negative
- Other
- 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 significant gastrointestinal disease that would preclude study participation
- No significant psychiatric disease that would preclude study participation
- No other medical condition that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 4 months after study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010)
- No prior gp100 antigen, MART-1 antigen, or tyrosinase peptide
- At least 4 weeks since prior immunotherapy for melanoma and recovered
- No other concurrent immunotherapy
- Chemotherapy
- At least 4 weeks since prior chemotherapy for melanoma (6 weeks for nitrosoureas) and recovered
- No concurrent chemotherapy
- Endocrine therapy
- At least 4 weeks since prior hormonal therapy for melanoma and recovered
- At least 4 weeks since prior systemic, inhaled, or topical corticosteroids
- No concurrent systemic, inhaled, or topical corticosteroids
- Radiotherapy
- At least 4 weeks since prior radiotherapy for melanoma and recovered
- Surgery
- See Disease Characteristics
- At least 4 weeks since prior surgery for melanoma and recovered
- Other
- No concurrent immunosuppressive agents (e.g., cyclosporine and its analog)
- Concurrent analgesic therapy allowed provided the dose is stable for the past 14 days
Exclusion
Key Trial Info
Start Date :
May 31 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2009
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00084656
Start Date
May 31 2004
End Date
October 31 2009
Last Update
April 14 2022
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497