Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

May 23, 2017 updated by: Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Maximum tolerated dose of B7-dendritic cell cross-linking antibody

Secondary Outcome Measures

Outcome Measure
Toxicity
Progression free survival and overall survival time
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2008

Primary Completion (Actual)

February 15, 2010

Study Completion (Actual)

May 22, 2012

Study Registration Dates

First Submitted

April 12, 2008

First Submitted That Met QC Criteria

April 12, 2008

First Posted (Estimate)

April 15, 2008

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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