Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: Drugs used in chemotherapy, such as dacarbazine and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Complete metastasectomy may be an effective treatment for metastatic melanoma and may improve quality of life and help patients live longer and more comfortably. It is not yet known whether complete metastasectomy is more effective than chemotherapy in treating stage IV melanoma. PURPOSE: This randomized phase III trial is studying dacarbazine and/or cisplatin to see how well they work compared to complete metastasectomy in treating patients with stage IV melanoma.


Study summary:

OBJECTIVES: Primary - Compare overall survival in patients with stage IV melanoma treated with complete metastasectomy vs dacarbazine and/or cisplatin. Secondary - Compare time to progression in patients treated with these regimens. - Determine the response rate in patients treated with dacarbazine and/or cisplatin. - Compare the morbidity and quality of life of patients treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to prior exposure to dacarbazine and cisplatin (yes vs no) and number of sites of metastases (1 vs 2 or more). Patients are randomized to 1 of 2 treatment arms. - Arm I (surgery): Patients undergo complete metastasectomy. Patients with disease progression after surgery may undergo repeat resection or may receive dacarbazine and/or cisplatin as in arm II. - Arm II (systemic therapy): Patients receive dacarbazine IV over 30-60 minutes and/or cisplatin IV over 30 minutes on days 1, 2, 3, 22, 23, and 24 (1 course). Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 1 additional course of chemotherapy beyond CR and are eligible for other investigational strategies. Quality of life is assessed at baseline, at 3 and 6 months, and at 1 year. Patients are followed every 3-4 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 74 patients (37 per treatment arm) will be accrued for this study within 4 years.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of metastatic melanoma - Solitary pulmonary nodule may not be sole site of metastatic disease - No disease limited to subcutaneous, cutaneous, or peripheral nodal (neck, axillary, groin, or iliac nodes) sites only - Measurable disease - Disease progression during or after prior interleukin-2 (IL-2)-based therapy OR ineligible for high-dose IL-2 therapy - Metastatic disease amenable to complete surgical resection - Less than 5% estimated mortality from surgery - Prior complete metastasectomy allowed provided disease did not recur within 6 months after surgery - No primary ocular or mucosal melanoma - No brain metastases PATIENT CHARACTERISTICS: Age - 16 and over Performance status - ECOG 0-2 Life expectancy - More than 3 months Hematopoietic - WBC at least 3,000/mm^3 OR - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No coagulation disorder Hepatic - Hepatitis B surface antigen negative - Hepatitis C antibody negative Renal - Creatinine no greater than 1.6 mg/dL OR - Creatinine clearance at least 70 mL/min - No major medical illness of the renal system Cardiovascular - No major medical illness of the cardiovascular system Pulmonary - No major medical illness of the respiratory system Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No active systemic infection - No form of primary or secondary immunodeficiency PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - No concurrent palliative radiotherapy Surgery - See Disease Characteristics - No concurrent palliative surgery Other - More than 3 weeks since prior therapy for melanoma (except surgery) - No other concurrent therapy for melanoma


NCT ID:

NCT00072124


Primary Contact:

Study Chair
Richard M. Sherry, MD
NCI - Surgery Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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