Melanoma (Skin)
Conditions
Keywords
recurrent melanoma, stage IV melanoma
Brief summary
RATIONALE: Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal antibody in treating patients with stage IV melanoma.
Detailed description
OBJECTIVES: Primary * Determine the safety/toxicity of a single dose of B7-dendritic cell cross-linking antibody containing plasma in treating patients with stage IV melanoma. Secondary * Describe the immunological changes (Th1/Th2 balance, frequency of tumor specific cytotoxic T lymphocytes, and plasma cytokine profiles) in the treated patients. * Determine the treatment impact on tumor growth (e.g., objective response, time to progression). OUTLINE: Patients receive B7-dendritic cell cross-linking antibody IV once on day 1. Patients undergo peripheral blood collection at baseline and periodically after infusion for analysis of dendritic cell activation, cytotoxic T-lymphocyte activity, immune cell impact, and serum cytokine changes using immunophenotyping and flow cytometry. After completion of study treatment patients are followed every 2 months for 5 years.
Interventions
BIOLOGICALB7-DC cross-linking antibody rHIgM12B7
OTHERflow cytometry
OTHERimmunologic technique
OTHERlaboratory biomarker analysis
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed melanoma * Stage IV disease (M1a and M1b only) * Measurable disease according to RECIST criteria * HLA-A2 positive * Must have IgA in serum (any concentration) * No known standard therapy for this disease that is potentially curative or proven capable of extending life expectancy PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Hemoglobin ≥ 10.0 g/dL * Platelet count ≥ 75,000/mm\^3 * AST ≤ 5 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to provide informed consent * Agrees to return to Mayo Clinic Rochester for follow-up * Agrees to participate in the mandatory translational research component of the study * No uncontrolled or current infection * No known immune deficiency * No B or AB blood grouping PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior chemotherapy and recovered * More than 4 weeks since prior biologic therapy * No concurrent immunosuppressive therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose of B7-dendritic cell cross-linking antibody | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival and overall survival time | — |
| Toxicity | — |
| Tumor response in terms of complete or partial response at 8 weeks | — |
| Tetramer response | — |
| Percent change in the number of T, B, NK cells, monocytes and dendritic cells from pretreatment levels as well as the percent change in plasma concentrations of various molecular components | — |
Countries
United States
Outcome results
None listed