Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: B7-DC cross-linking antibody rHIgM12B7
* Other: flow cytometry
* Other: immunologic technique
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: B7-DC cross-linking antibody rHIgM12B7|nan|
|Other: flow cytometry|nan|
|Other: immunologic technique|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of B7-dendritic cell cross-linking antibody |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent melanoma, stage IV melanoma