NCT00658892

Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	B7-DC cross-linking antibody rHIgM12B7
OTHER	flow cytometry
OTHER	immunologic technique
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2008-04-08
• Primary completion: 2010-02-15
• Completion: 2012-05-22
• First posted: 2008-04-15
• Last updated: 2017-05-25

Locations

1 site across 1 country: United States