Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

Phase 1

Completed

• Conditions: Melanoma (Skin)

• Registration Number: NCT00658892
• Lead Sponsor: Mayo Clinic

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-04-08
• Study First Submitted: 2008-04-12
• Study First Submitted QC: 2008-04-12
• Study First Posted: 2008-04-15
• Primary Completion: 2010-02-15
• Study Completion: 2012-05-22
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of B7-dendritic cell cross-linking antibody

Secondary Outcome Measures

Name	Time	Method
Tumor response in terms of complete or partial response at 8 weeks
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
Toxicity
Tetramer response
Progression free survival and overall survival time

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States