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
  Purpose

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 Intervention Phase
Melanoma (Skin)
Biological: B7-DC cross-linking antibody rHIgM12B7
Other: flow cytometry
Other: immunologic technique
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Maximum tolerated dose of B7-dendritic cell cross-linking antibody [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 18
Study Start Date: April 2008
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658892

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Svetomir Markovic, M.D., Ph.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Svetomir Nenad Markovic, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00658892     History of Changes
Other Study ID Numbers: CDR0000593085, P30CA015083, MC0677, 06-006992, NCI-2009-01343
Study First Received: April 12, 2008
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
recurrent melanoma
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014