Expired Study
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Baltimore, Maryland 21231


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00003802


Primary Contact:

Study Chair
William H. Sharfman, MD
Sidney Kimmel Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21231
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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