3-AP in Treating Patients With Previously Untreated Locally Recurrent or Metastatic Renal Cell Carcinoma
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed renal cell carcinoma Locally recurrent OR metastatic disease Incurable by standard therapy Clinically and/or radiologically measurable disease At least 1 unidimensionally measurable lesion* at least 20 mm by x-ray, physical exam, or non-spiral CT scan OR at least 10 mm by spiral CT scan If the sole site of measurable disease is in a previously irradiated field, there must be documented disease progression at that site NOTE: *Bone lesions are not considered measurable disease No documented brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No glucose-6-phosphate dehydrogenase (G6PD) deficiency* NOTE: *Screening for G6PD deficiency is required for patients of African, Asian, or Mediterranean descent Hepatic Bilirubin normal AST or ALT no greater than 2.5 times upper limit of normal (ULN) Renal Creatinine no greater than 1.5 times ULN Creatinine clearance at least 50 mL/min Cardiovascular No myocardial infarction within the past 6 months No symptomatic congestive heart failure No unstable angina No active cardiomyopathy No cardiac arrhythmia No uncontrolled hypertension Pulmonary No pulmonary disease requiring oxygen Immunologic HIV negative No known hypersensitivity to compounds of similar chemical or biological composition to 3-AP (Triapine®) No active uncontrolled or serious infection No immunodeficiency Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor with no evidence of disease for at least 5 years No history of significant neurologic or psychiatric disorder (e.g., uncontrolled psychotic disorders) that would preclude giving informed consent or complying with study requirements No active peptic ulcer disease No other serious illness or medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy More than 3 months since prior interferon for advanced or recurrent disease No other prior immunotherapy for advanced or recurrent disease No prior gene therapy Chemotherapy No prior systemic chemotherapy for advanced or recurrent disease Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy (except low-dose nonmyelosuppressive radiotherapy) and recovered Surgery At least 2 weeks since prior major surgery Other No prior investigational anticancer agents No other concurrent anticancer agents or therapy No other concurrent investigational therapy No concurrent anticoagulants Concurrent nontherapeutic warfarin or heparin allowed
Sites / Locations
- Cross Cancer Institute
- British Columbia Cancer Agency
- CancerCare Manitoba
- Margaret and Charles Juravinski Cancer Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Toronto Sunnybrook Regional Cancer Centre
- Toronto General Hospital
- Centre Hospitalier de l'Universite de Montreal