Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
Recruitment status was Active, not recruiting
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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 3 |
| 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 |
- Disease-free survival [ Designated as safety issue: No ]
- Duration of survival [ Designated as safety issue: No ]
- Toxicity as assessed by CTC v2 [ Designated as safety issue: Yes ]
| Study Start Date: | December 1999 |
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.
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
- T3 or T4, N0, M0
- Must originate in the skin
Wide excision with a minimum of 1-2 cm margin surrounding primary lesion or biopsy scar
- No more than 56 days since definitive surgical treatment (wide excision)
- No more than 12 weeks since primary surgery
- No clinical, radiological, or pathological evidence of incompletely resected disease, lymph node metastases, in-transit metastasis, or any distant metastatic disease
PATIENT CHARACTERISTICS:
Age:
- 18 to 80
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9.8 g/dL
Hepatic:
- SGOT/SGPT no greater than 2 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2 times ULN
- LDH no greater than 2 times ULN
- Bilirubin no greater than 2 times ULN
- Hepatitis B and C negative
Renal:
- Creatinine normal
Other:
- Not pregnant or nursing
- Negative pregnancy test
- No prior or other concurrent cancer except carcinoma in situ of the cervix or basal or squamous cell skin cancer
- No autoimmune disorders
- No conditions requiring systemic treatment with immunosuppressive drugs including treatment with systemic corticosteroids
- No history of CNS demyelinating or inflammatory disease
- No hereditary or acquired peripheral neuropathy
- No other significant medical or surgical condition or psychiatric disorders requiring medication that would preclude study
- No history of severe allergic reaction to shellfish
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy
- No other concurrent biologic therapy
Chemotherapy:
- No prior systemic chemotherapy
- No concurrent cytotoxic chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except replacement therapy
- No concurrent corticosteroids
- No concurrent chronic systemic steroids
Radiotherapy:
- No prior adjuvant radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No prior preoperative infusion or perfusion therapy
- No concurrent immunosuppressive medications
- No other concurrent anticancer therapy
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
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by National Cancer Institute (NCI):
|
stage II melanoma |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 19, 2013