A Phase II Trial of Pyrazoloacridine (NSC 366140, IND 36325) in Metastatic Cutaneous and Ocular Melanoma

Date de début de l'étude : 1 février 1999

DISEASE CHARACTERISTICS: Histologically confirmed metastatic cutaneous or ocular melanoma that is chemotherapy naive Bidimensionally measurable disease No pleural effusions or ascites No untreated CNS metastases Stable brain metastases by CT or MRI scan At least 4 weeks since prior steroid therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 4,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN (unless due to hepatic metastases) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection No known hypersensitivity to E.coli derived proteins No other serious medical problems No more than 1 primary malignancy within past 5 years, other than: Nonmelanomatous skin cancer Carcinoma in situ of the cervix No history of spinal cord compression PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed (e.g., interleukin-2, interferon alfa, or vaccine therapy) Chemotherapy: No prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: Prior radiotherapy for primary ocular melanoma, brain metastases, or to metastatic sites encompassing less than 25% of the bone marrow allowed No other prior radiotherapy Surgery: At least 2 weeks since prior surgery and recovered