RATIONALE: 2-Methoxyestradiol may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors.
OBJECTIVES: * Determine the maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors. * Determine the side effect profile of this drug in these patients. * Determine the pharmacokinetic profile of this drug in these patients. * Determine the changes in positron-emission tomography scans of patients treated with this drug. * Determine the changes in apotosis in patients treated with this drug. OUTLINE: This is a dose-escalation study. Patients receive oral 2-methoxyestradiol (2ME2) once on day 1 followed by 2 days of evaluation. Patients then receive oral 2ME2 every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 2ME2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at day 30. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
NCI - Center for Cancer Research
Bethesda, Maryland, United States
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