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Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00658892
Collaborator
National Cancer Institute (NCI) (NIH)
7
Enrollment
1
Location
49.4
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: B7-DC cross-linking antibody rHIgM12B7
  • Other: flow cytometry
  • Other: immunologic technique
  • Other: laboratory biomarker analysis
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study
Actual Study Start Date :
Apr 8, 2008
Actual Primary Completion Date :
Feb 15, 2010
Actual Study Completion Date :
May 22, 2012

Outcome Measures

Primary Outcome Measures

  1. Maximum tolerated dose of B7-dendritic cell cross-linking antibody []

Secondary Outcome Measures

  1. Progression free survival and overall survival time []

  2. Toxicity []

  3. Tumor response in terms of complete or partial response at 8 weeks []

  4. Tetramer response []

  5. 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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Svetomir Markovic, M.D., Ph.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00658892
Other Study ID Numbers:
  • CDR0000593085
  • P30CA015083
  • MC0677
  • 06-006992
  • NCI-2009-01343
First Posted:
Apr 15, 2008
Last Update Posted:
May 25, 2017
Last Verified:
May 1, 2017
Keywords provided by Mayo Clinic
recurrent melanoma
stage IV melanoma
Additional relevant MeSH terms:
Melanoma
Antibodies

Study Results

No Results Posted as of May 25, 2017