Finding studies
Finding studies
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Lead
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
With
OBJECTIVES: * Determine the maximum tolerated dose of gefitinib when given in combination with temozolomide in patients with malignant primary glioma. * Determine the toxic effects of this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a multicenter, dose-escalation study of gefitinib. Patients are stratified according to use of concurrent enzyme-inducing anti-epileptic drugs (yes vs no). Patients receive oral gefitinib once daily on days 1-35 and oral temozolomide once daily on days 8-12 for the first course only. For the second and subsequent courses, patients receive oral gefitinib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gefitinib 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 every 2 months for 1 year and then every 3-6 months thereafter. PROJECTED ACCRUAL: Approximately 3-42 patients will be accrued for this study within 1-14 months.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
