Melanoma (Skin) Clinical Trial
Official title:
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
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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