Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

NCT00658892 | Completed Phase 1

• 5 other identifiers: CDR0000593085P30CA015083MC067706-006992NCI-2009-01343
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of B7-dendritic cell cross-linking antibody

Secondary Outcomes (5)

• Progression free survival and overall survival time

• Toxicity

• 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

Interventions

B7-DC cross-linking antibody rHIgM12B7 BIOLOGICAL

flow cytometry OTHER

immunologic technique OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Flow Cytometry; Immunologic Techniques

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Svetomir Markovic, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2008
• First Posted: April 15, 2008
• Study Start: April 8, 2008
• Primary Completion: February 15, 2010
• Study Completion: May 22, 2012
• Last Updated: May 25, 2017

Record last verified: 2017-05

Locations

US (1)