Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Melanoma (Skin)

Treatments: Other: flow cytometry; Biological: B7-DC cross-linking antibody rHIgM12B7; Other: immunologic technique; Other: laboratory biomarker analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00658892

P30CA015083 (U.S. NIH Grant/Contract)

MC0677 (Other Identifier)

06-006992 (Other Identifier)

CDR0000593085

NCI-2009-01343 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)