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

NCT00005052 Phase 3 UNKNOWN

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.

Details

Lead sponsor	European Organisation for Research and Treatment of Cancer - EORTC
Phase	Phase 3
Status	UNKNOWN
Start date	1999-12

Conditions

• Melanoma (Skin)

Interventions

• GM2-KLH vaccine
• QS21
• adjuvant therapy

Primary outcomes

• Disease-free survival

Countries

Australia, Belgium, Denmark, Estonia, Finland, France, Germany, Israel, Italy, Netherlands, Norway, Poland, Portugal, Russia, Serbia, Spain, Switzerland, United Kingdom