Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma

• Status: Completed
• Trial end date: 2002-10-01
• 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.

PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating patients who have metastatic skin or eye melanoma.

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

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: NSC 366140

Criteria

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