Status:
COMPLETED
Monoclonal Antibody With or Without gp100 Peptides Plus Montanide ISA-51 in Treating Patients With Stage IV Melanoma
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines made from gp100 peptides may make the body build an ...
Detailed Description
OBJECTIVES: Primary * Determine the clinical response in patients with stage IV melanoma treated with escalating doses of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-01...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed stage IV melanoma
- Clinically evaluable or measurable disease
- No mucosal or ocular melanoma
- PATIENT CHARACTERISTICS:
- Age
- 16 and over
- Performance status
- ECOG 0-2
- Life expectancy
- At least 6 months
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- Hematocrit ≥ 28%
- WBC ≥ 2,500/mm\^3
- Hepatic
- AST ≤ 3 times upper limit of normal (ULN)
- Bilirubin ≤ ULN (\< 3 mg/dL for patients with Gilbert's syndrome)
- Hepatitis B surface antigen negative
- Hepatitis C virus antibody negative
- Renal
- Creatinine \< 2 mg/dL
- Immunologic
- HIV negative
- No history of any of the following:
- Inflammatory bowel disease
- Regional enteritis
- Connective tissue disorders (e.g., systemic lupus erythematosus)
- Rheumatoid arthritis
- Autoimmune inflammatory eye disease
- Sjögren's syndrome
- Inflammatory neurologic disorder (e.g., multiple sclerosis)
- No active infection
- No active autoimmune disease that may cause life-threatening symptoms or severe organ/tissue damage
- Vitiligo, autoimmune thyroiditis, or skin rashes associated with prior therapy are allowed if patient has recovered to grade 1 or less toxicity
- No systemic hypersensitivity to study agents
- Prior local reaction (e.g., delayed hypersensitivity or glaucomatous reactions) to Montanide ISA-51 or gp100 injections allowed
- No autoimmune disease requiring active therapy with any form of steroid or immunosuppressant
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent underlying medical condition that would preclude study participation
- 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
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
- Prior therapy with gp100 peptides or any other immunotherapy allowed
- Chemotherapy
- At least 6 weeks since prior nitrosoureas and recovered (toxicity no greater than grade 1)
- No concurrent chemotherapy
- Endocrine therapy
- At least 4 weeks since prior steroids
- No concurrent systemic, inhaled, optical, or topical corticosteroids
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- At least 3 weeks since prior systemic therapy for melanoma and recovered (toxicity no greater than grade 1)
- No concurrent immunosuppressive agents (e.g., cyclosporine)
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00077532
Start Date
March 1 2004
End Date
February 1 2008
Last Update
June 22 2012
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182