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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 I trial to study the effectiveness of chemotherapy using sarCNU in patients who have advanced solid tumors.
OBJECTIVES: I. Determine the maximum tolerated dose of SarCNU in patients with advanced solid malignancies. II. Determine the toxic effects of SarCNU in these patients. III. Characterize the pharmacokinetic profile of this regimen in these patients. IV. Determine any evidence of antineoplastic activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients receive oral SarCNU on days 1, 5, and 9. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SarCNU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD.
PROJECTED ACCRUAL: Approximately 12-36 patients will be accrued for this study.
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Jewish General Hospital - Montreal
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:34-0400
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A transplantable, poorly differentiated malignant tumor which appeared originally as a spontaneous breast carcinoma in a mouse. It grows in both solid and ascitic forms.
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