Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
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.
|Melanoma (Skin)||Biological: B7-DC cross-linking antibody rHIgM12B7 Other: flow cytometry Other: immunologic technique Other: laboratory biomarker analysis||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study|
- Maximum tolerated dose of B7-dendritic cell cross-linking antibody
- Progression free survival and overall survival time
- 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
|Actual Study Start Date:||April 8, 2008|
|Study Completion Date:||May 22, 2012|
|Primary Completion Date:||February 15, 2010 (Final data collection date for primary outcome measure)|
- Determine the safety/toxicity of a single dose of B7-dendritic cell cross-linking antibody containing plasma in treating patients with stage IV melanoma.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658892
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Svetomir Markovic, M.D., Ph.D.||Mayo Clinic|