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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| MC0677 | Other Identifier | Mayo Clinic Cancer Center | |
| 06-006992 | Other Identifier | Mayo Clinic IRB | |
| NCI-2009-01343 | Registry Identifier | NCI-CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B7-DC cross-linking antibody rHIgM12B7 | Biological | |||
| flow cytometry | Other | |||
| immunologic technique | Other | |||
| laboratory biomarker analysis | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of B7-dendritic cell cross-linking antibody |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival and overall survival time | ||
| Toxicity | ||
| Tumor response in terms of complete or partial response at 8 weeks |
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DISEASE CHARACTERISTICS:
Histologically confirmed melanoma
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Svetomir Markovic, M.D., Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D005434 | Flow Cytometry |
| D007158 | Immunologic Techniques |
| ID | Term |
|---|---|
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 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 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |