Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

Mayo Clinic7 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Melanoma (Skin)

Interventions

B7-DC cross-linking antibody rHIgM12B7BIOLOGICAL

flow cytometryOTHER

immunologic techniqueOTHER

laboratory biomarker analysisOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Maximum tolerated dose of B7-dendritic cell cross-linking antibody

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.