Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

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

Conditions
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Intraocular Melanoma, Melanoma (Skin)

Intervention / Treatment
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* Drug: pyrazoloacridine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pyrazoloacridine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iris melanoma, ciliary body and choroid melanoma, small size, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma, stage IV melanoma, recurrent melanoma