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Vaccine Therapy in Treating Patients With Stage IV Melanoma

Phase 2
Completed
Conditions
Melanoma (Skin)
Registration Number
NCT00042783
Lead Sponsor
SWOG Cancer Research Network
Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine therapy may be effective in treating stage IV melanoma.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.

Detailed Description

OBJECTIVES:

* Determine the feasibility of treating patients with stage IV melanoma with D1/3-MAGE-3-His fusion protein with SB-AS02B adjuvant.

* Determine the clinically confirmed response rates (partial and complete responses) of patients treated with this regimen.

* Determine the 6-month progression-free survival rate of patients treated with this regimen.

* Determine the qualitative and quantitative toxic effects of this regimen in these patients.

* Determine immune responses in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive D1/3-MAGE-3-His fusion protein emulsified in SB-AS02B adjuvant intramuscularly once every 3 weeks for a total of 12 weeks (4 injections). In the absence of disease progression or unacceptable toxicity, patients receive a second 12-week course beginning at week 16.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (7)

Arizona Cancer Center at University of Arizona Health Sciences Center

πŸ‡ΊπŸ‡Έ

Tucson, Arizona, United States

USC/Norris Comprehensive Cancer Center and Hospital

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

Barbara Ann Karmanos Cancer Institute

πŸ‡ΊπŸ‡Έ

Detroit, Michigan, United States

Veterans Affairs Medical Center - Biloxi

πŸ‡ΊπŸ‡Έ

Biloxi, Mississippi, United States

CCOP - Columbia River Oncology Program

πŸ‡ΊπŸ‡Έ

Portland, Oregon, United States

University of Washington School of Medicine

πŸ‡ΊπŸ‡Έ

Seattle, Washington, United States

Arizona Cancer Center at University of Arizona Health Sciences Center
πŸ‡ΊπŸ‡ΈTucson, Arizona, United States

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