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Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

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ClinicalTrials.gov Identifier: NCT00658892
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : May 25, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Tracking Information
First Submitted Date  ICMJE April 12, 2008
First Posted Date  ICMJE April 15, 2008
Last Update Posted Date May 25, 2017
Actual Study Start Date  ICMJE April 8, 2008
Actual Primary Completion Date February 15, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2008)
Maximum tolerated dose of B7-dendritic cell cross-linking antibody
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00658892 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2008)
  • Progression free survival and overall survival time
  • Toxicity
  • Tumor response in terms of complete or partial response at 8 weeks
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
Official Title  ICMJE B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study
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 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.

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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma (Skin)
Intervention  ICMJE
  • Biological: B7-DC cross-linking antibody rHIgM12B7
  • Other: flow cytometry
  • Other: immunologic technique
  • Other: laboratory biomarker analysis
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2017)
7
Original Enrollment  ICMJE
 (submitted: April 12, 2008)
18
Actual Study Completion Date  ICMJE May 22, 2012
Actual Primary Completion Date February 15, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00658892
Other Study ID Numbers  ICMJE CDR0000593085
P30CA015083 ( U.S. NIH Grant/Contract )
MC0677 ( Other Identifier: Mayo Clinic Cancer Center )
06-006992 ( Other Identifier: Mayo Clinic IRB )
NCI-2009-01343 ( Registry Identifier: NCI-CTRP )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Svetomir Markovic, M.D., Ph.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2017

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