Vaccine Therapy in Treating Patients With Primary Stage II Melanoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: GM2-KLH vaccine
* Biological: QS21
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: GM2-KLH vaccine|nan|
|Biological: QS21|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of survival |  |  | 
| Toxicity as assessed by CTC v2 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II melanoma