Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma

• Status: Completed
• Trial end date: 2005-06-01
• 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. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa 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: Dacarbazine; Interferon-alpha; Interferons; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant melanoma

• Unresectable stage III or stage IV disease

• Ocular, mucosal, or cutaneous melanoma

• Measurable disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 150,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGOT/SGPT no greater than 3 times ULN

• Alkaline phosphatase no greater than 3 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No history of severe cardiovascular disease

• No myocardial infarction within the past 6 months

• No unstable angina

• No New York Heart Association class III or IV heart disease (congestive heart failure)

• No ventricular tachyarrhythmias

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No AIDS-related illness

• No frequent vomiting or other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)

• No serious infection requiring IV antibiotics

• No psychiatric disorder requiring ongoing therapy or medication

• No nonmalignant illness or other medical condition that would preclude study

• No other active malignancy within the past 2 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer detected initially during transurethral resection of the prostate (TURP) (comprising less than 5% of resected tissue) with PSA level normal since TURP

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior biologic therapy or immunotherapy and recovered

• No concurrent immunotherapy

Chemotherapy:

• No prior dacarbazine

• No prior temozolomide

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent systemic corticosteroids

Radiotherapy:

• At least 3 weeks since prior radiotherapy, interstitial brachytherapy, or radiosurgery

• At least 3 weeks since prior radiotherapy to the brain for brain metastases

• Prior radiotherapy to indicator lesions allowed if there is evidence of disease progression

• Recovered from prior radiotherapy

• No concurrent radiotherapy

Surgery:

• At least 2 weeks since prior surgical procedure requiring general anesthesia and recovered