Status:
COMPLETED
Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief 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 s...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 8 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00658892
Start Date
April 8 2008
End Date
May 22 2012
Last Update
May 25 2017
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905