Status:
COMPLETED
Dacarbazine and/or Cisplatin Compared With Complete Metastasectomy in Treating Patients With Stage IV Melanoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
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 effect...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00072124
Start Date
September 1 2003
End Date
May 1 2005
Last Update
June 19 2013
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182