A Phase II Study of Temozolomide (Temodar) and Peglated Interferon Alfa-2B (PEGIntron) in the Treatment of Advanced Melanoma
Inclusion 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