Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

Melanoma (Skin) Clinical Trial

Official title:

B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658892
• Other study ID #: CDR0000593085
• Secondary ID: P30CA015083MC067
• Status: Completed
• Phase: Phase 1
• First received: April 12, 2008
• Last updated: May 23, 2017
• Start date: April 8, 2008
• Est. completion date: May 22, 2012

Study information

• Verified date: May 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 22, 2012
• Est. primary completion date: February 15, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• B7-DC cross-linking antibody rHIgM12B7

Other:
• flow cytometry

• immunologic technique

• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of B7-dendritic cell cross-linking antibody
Secondary	Progression free survival and overall survival time
Secondary	Toxicity
Secondary	Tumor response in terms of complete or partial response at 8 weeks
Secondary	Tetramer response
Secondary	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