Melanoma (Skin) Clinical Trial
Official title:
A Prospective Random Assignment Trial Comparing Complete Metastasectomy to Chemotherapy for Selected Patients With Stage IV Melanoma
Verified date | January 2005 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | May 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
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