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Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00658892
First received: April 12, 2008
Last updated: March 24, 2014
Last verified: March 2014

April 12, 2008
March 24, 2014
April 2008
February 2010   (final data collection date for primary outcome measure)
Maximum tolerated dose of B7-dendritic cell cross-linking antibody [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00658892 on ClinicalTrials.gov Archive Site
  • Progression free survival and overall survival time [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Tumor response in terms of complete or partial response at 8 weeks [ Designated as safety issue: No ]
  • Tetramer response [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study

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

  • 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.

Interventional
Phase 1
Primary Purpose: Treatment
Melanoma (Skin)
  • Biological: B7-DC cross-linking antibody rHIgM12B7
  • Other: flow cytometry
  • Other: immunologic technique
  • Other: laboratory biomarker analysis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18
Not Provided
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00658892
CDR0000593085, P30CA015083, MC0677, 06-006992, NCI-2009-01343
Not Provided
Svetomir Nenad Markovic, M.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Svetomir Markovic, M.D., Ph.D. Mayo Clinic
Mayo Clinic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP