RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating patients
who have metastatic skin or eye melanoma.
- Assess the antitumor activity of pyrazoloacridine (PZA) in chemotherapy naive patients
with metastatic cutaneous or ocular melanoma.
- Determine the toxic effects of PZA in this patient population.
- Determine the pharmacokinetic profile of PZA in these patients.
OUTLINE: Patients are stratified into cutaneous or ocular melanoma treatment groups.
Patients receive pyrazoloacridine IV over 3 hours on day 1. Treatment continues every 21
days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 28-70 patients will be accrued for this study.
- Histologically confirmed metastatic cutaneous or ocular melanoma that is chemotherapy
- 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
- 18 and over
- ECOG 0-2
- At least 12 weeks
- WBC at least 4,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- 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)
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
- 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:
- Prior biologic therapy allowed (e.g., interleukin-2, interferon alfa, or vaccine
- No prior chemotherapy
- See Disease Characteristics
- 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
- At least 2 weeks since prior surgery and recovered