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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005052 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: GM2-KLH vaccine Biological: QS21 Procedure: adjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Start Date: | December 1999 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 1300 patients (650 per arm) will be accrued for this study within 36 months.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary stage II melanoma greater than 1.5 mm without evidence of lymph node metastases
Wide excision with a minimum of 1-2 cm margin surrounding primary lesion or biopsy scar
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 80 Study Locations| Investigator: | Alexander M. M. Eggermont, MD, PhD | Daniel Den Hoed Cancer Center at Erasmus Medical Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00005052 History of Changes |
| Other Study ID Numbers: | CDR0000067645, EORTC-18961, BMS-CA152-003 |
| Study First Received: | April 6, 2000 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
|
stage II melanoma |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
Nevi and Melanomas Adjuvants, Immunologic QS 21 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |