Melanoma
Conditions
Keywords
Stage III melanoma, Stage IV melanoma, Interleukin-12, Cancer Vaccines, Antineoplastic Agents, Combined, Incomplete Freund's adjuvant, Monophenol Monooxygenase, Mannitol, Adjuvants, Immunologic, Melan-A Protein, Antigens, Neoplasm, Antibodies, Melanocyte lineage-specific antigen gp100, CTLA-4
Brief summary
This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV melanoma.
Detailed description
In the Phase I/II trial, patients with resected stages III and IV melanoma who have been rendered free of disease, but are at high risk of relapse, are treated with peptides/IFA at a dose of 0.5 mg each peptide plus CTLA-4 antibody given intravenously, 3 mg/kg, after each vaccination. In the Phase II randomized study, patients are treated with the melanoma peptide vaccine alone, with CTLA-4 antibody, or with CTLA-4 antibody combined with IL-12 at 30 ng/kg with alum. The peptides are tyrosinase 368-376 (370D); gp100 209-217 (210M); and MART-1 26-35 (27L) which are emulsified with IFA. The dosing schedule for both trials are at 1, 2, 3, 4, 5, and 6 months; then at 9 and 12 for a total of 8 vaccinations.
Interventions
BIOLOGICALMDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine
Sponsors
University of Southern California
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of stage III or IV cutaneous, mucosal, or ocular melanoma * Completely resected disease or disease-free * HLA-A2.1 positive * Tumor tissue available for immunohistochemical analysis and staining positive for at least 1 of the specified antigens * At least 1 month since prior therapy for cancer, including radiotherapy and adjuvant therapy * WBC count at least 3,000/mm3 * Granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9.0 gm/dL * Creatinine no greater than 2.0 mg/dL * Bilirubin no greater than 2.0 mg/dL * SGOT/SGPT no greater than 2.5 times upper limit of normal * ECOG performance status 0-1 * Have failed alpha-interferons (patients with resected stage III disease)
Exclusion criteria
* Prior treatment with tyrosinase: 368-376(370D), gp100:209-217(210M), and MART-1:26-35(27L) peptides * Steroid therapy or other immunosuppressive medication requirement * Major systemic infections (e.g., pneumonia or sepsis) * Coagulation or bleeding disorders * Major medical illnesses of the gastrointestinal, cardiovascular, or respiratory systems * Allergic reaction to Montanide ISA 51 (incomplete Freund's adjuvant) * History of uveitis or autoimmune inflammatory eye disease * Other active autoimmune disease * Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody * Pregnant or nursing
Countries
United States
Outcome results
None listed