Finding studies
Finding studies
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Lead
NYU Langone Health
With
OBJECTIVES: * Determine the dose-limiting toxic effects of R115777 and topotecan in patients with advanced solid tumors. * Determine the maximum tolerated dose of this regimen in these patients. * Determine pharmacokinetic profiles of topotecan alone and in combination with R115777 in these patients. * Measure the inhibition of ras-farnesylation and topo-1 inhibition in peripheral blood mononuclear cells in these patients when treated with this regimen. * Determine activity of this treatment in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral R115777 twice daily on days 2-21 (in the first course only R115777 begins on day 3) and topotecan IV continuously on days 1-21. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
