Vaccine Therapy in Treating Patients With Primary Stage II Melanoma

Phase 3

• Conditions: Melanoma (Skin)

• Registration Number: NCT00005052
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 1999-12
• Study First Submitted: 2000-04-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2006-01
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival

Secondary Outcome Measures

Name	Time	Method
Duration of survival
Toxicity as assessed by CTC v2

Trial Locations

Locations (79)

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

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