Carboplatin and Temozolomide in Treating Patients With Unresectable or Metastatic Melanoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and temozolomide in treating patients who have unresectable or metastatic melanoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mount Vernon Cancer Centre at Mount Vernon Hospital
• Treatments: Carboplatin; Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS: Histologically proven unresectable or metastatic melanoma

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: Hemoglobin greater than 10 g/dL WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.8 mg/dL AST less than 3 times upper limit of normal (ULN) Alkaline phosphatase less than 3 times ULN No hepatitis B Renal: Creatinine less than 1.4 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: No New York Heart Association class II cardiac disease Pulmonary: No pulmonary disease requiring oxygen therapy Other: Not pregnant Fertile patients must use effective contraception during study and for 3 months following No concurrent serious nonmalignant disease No AIDS No uncontrolled infection No uncontrolled diabetes No medical condition that will interfere with taking oral temozolomide

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No prior carboplatin and temozolomide No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered At least 3 weeks since prior palliative radiotherapy No concurrent radiotherapy Surgery: No concurrent surgery to tumor Other: No other concurrent investigational agent