B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of B7-dendritic cell cross-linking antibody
Safety Issue:
Yes
Principal Investigator
Svetomir Markovic, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000593085
NCT ID:
NCT00658892
Start Date:
April 2008
Completion Date:
Related Keywords:
- Melanoma (Skin)
- recurrent melanoma
- stage IV melanoma
- Melanoma
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
