Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma

• Status: Completed
• Trial end date: 2003-02-01
• 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/II trial to study the effectiveness of combination chemotherapy consisting of acetaminophen plus carmustine in treating patients who have stage III or stage IV melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Acetaminophen; Acetylcysteine; Carmustine; N-monoacetylcystine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IV melanoma or stage III melanoma not potentially curable by surgery

• Phase I: (closed to accrual 3/7/2001) measurable or evaluable disease required

• Phase II: At least 2 measurable subcutaneous or cutaneous metastases that are accessible for biopsy

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm^3

• Hemoglobin at least 9 g/dL

• Platelet count at least 100,000/mm^3

• No active bleeding

Hepatic:

• AST less than 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase less than 1.5 times ULN

• PT/PTT within normal range

Renal:

• Not specified

Pulmonary:

• No interstitial lung disease or unexplained interstitial infiltrates on chest x-ray

• No chronic obstructive pulmonary disease

• No asthma requiring treatment

Other:

• No active infection requiring antimicrobial drugs

• Not pregnant or nursing

• Fertile patients must use effective barrier contraception

• No allergies to acetaminophen or acetylcysteine

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for mitomycin)

• No prior nitrosoureas

• No prior hepatic perfusions with chemotherapy

Endocrine therapy:

• No concurrent oral contraceptives

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• Not specified

Other:

• No concurrent vitamin, mineral, or garlic supplements

• At least 7 days since prior garlic or alcohol

• No concurrent treatment with medications known to affect P450 hepatic enzymes

• No concurrent treatment with calcium channel blockers