NCT00042783

Vaccine Therapy in Treating Patients With Stage IV Melanoma

A Phase II Trial Of A D1/3-MAGE3-HIS Fusion Protein (NSC-719274) With Adjuvant SBAS02B (NSC-719275) For Patients With Stage IV, M1a or M1b Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	D1/3-MAGE-3-His fusion protein
BIOLOGICAL	SB-AS02B adjuvant

Timeline

• Start date: 2002-09-01
• Completion: 2006-03-01
• First posted: 2003-01-27
• Last updated: 2013-06-24

Locations

7 sites across 1 country: United States