Melanoma (Skin) Clinical Trial
Official title:
Adjuvant Ganglioside GM2-KLH/QS-21 Vaccination: Post-Operative Adjuvant Ganglioside GM2-KLH/QS-21 (BMS-248479) Vaccination Treatment After Resection of Primary Cutaneous Melanoma Thicker Than 1.5mm (AJCC/UICC Stage II, T3-T4N0M0), a 2-Arm Multicenter Randomized Phase III Trial vs. Observation
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is
not yet known whether vaccine therapy is more effective than observation alone for melanoma.
PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it
works compared to observation alone in treating patients with primary stage II melanoma.
OBJECTIVES:
- Compare the effect of immunization with GM2-KLH and QS21 to observation on the
disease-free survival of patients with primary cutaneous stage II melanoma after
adequate surgery.
- Determine overall survival and toxicity in the two treatment arms.
OUTLINE: This is a randomized, open-label, parallel, multicenter study. Patients are
stratified according to participating center, tumor thickness (greater than 1.5 to 3.0 mm vs
greater than 3.0 to 4.0 mm vs greater than 4.0 mm), gender, ulceration (yes vs no), and
presence of additional staging procedures of regional lymph nodes (yes vs no). Patients are
randomized to one of two arms.
- Arm I: Patients are vaccinated with GM2-KLH and QS21 subcutaneously on day 1 of weeks
1-4, 12, 24, 36, 48, 60, 72, 84, 96, 120, and 144 for a total of 14 vaccinations.
- Arm II: Patients undergo observation. Patients are followed every 6 months for 7 years.
PROJECTED ACCRUAL: A total of 1300 patients (650 per arm) will be accrued for this study
within 36 months.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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