B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study
- 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
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.
Primary Purpose: Treatment
Maximum tolerated dose of B7-dendritic cell cross-linking antibody
Svetomir Markovic, M.D., Ph.D.
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|