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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Disease-free survival
Duration of survival
Toxicity as assessed by CTC v2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Royal Perth Hospital
Perth, Western Australia, Australia
Hopital Universitaire Erasme
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Hopital de Jolimont
Haine-Saint-Paul, Belgium
U.Z. Gasthuisberg
Leuven, Belgium
Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
Aarhus, Denmark
Rigshospitalet - Copenhagen University Hospital
Copenhagen, Denmark
Herlev Hospital - University Hospital of Copenhagen
Copenhagen, Denmark
...and 70 more locations