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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00042783
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date September 2002
Completion date March 2006

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