A Phase II Trial of Pyrazoloacridine (NSC 366140, IND 36325) in Metastatic Cutaneous and Ocular Melanoma
pyrazoloacridine
Eye Diseases+14
+ Eye Neoplasms
+ Neoplasms
Treatment Study
Summary
Study start date: February 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United StatesOpen Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Google Maps