Finding studies
Finding studies
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Lead
The University of Texas Health Science Center at San Antonio
With
OBJECTIVES: I. Determine the maximum tolerated dose of mitomycin when administered with irinotecan in patients with advanced solid tumors. II. Determine whether the pharmacokinetic profile of irinotecan is altered by prior administration of mitomycin in this patient population. III. Determine the effect of irinotecan and mitomycin on the expression of DT-Diaphorase and the Topo I gene. IV. Determine the preliminary antitumor activity of this regimen in these patients. OUTLINE: This is a dose escalation study. Patients receive mitomycin IV over 20 to 30 minutes on day 1 and irinotecan IV over 90 minutes on days 2, 8, 15, and 22, followed by 2 weeks of rest beginning on day 29. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients each receive escalating doses of mitomycin and irinotecan until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity. Patients are followed for 1 month. PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
