Brain and Central Nervous System Tumors Clinical Trial
Official title:
Oral ST1481 in Adults With Malignant Glioma: A Phase I-II Clinical Trial
RATIONALE: Drugs used in chemotherapy, such as gimatecan, work in different ways to stop
tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gimatecan in
treating patients with recurrent or progressive primary malignant glioma.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of gimatecan in patients with recurrent or
progressive primary malignant glioma treated with or without concurrent enzyme-inducing
anticonvulsant drugs.
- Determine whether this drug has sufficient activity to warrant further development in
these patients. (phase II)
Secondary
- Determine the qualitative and quantitative toxic effects of this drug in these
patients.
- Determine the pharmacokinetic behaviors of this drug in these patients.
- Correlate the principal toxic effects with the pertinent pharmacokinetic parameters of
this drug in these patients.
- Determine the antitumor activity of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients are stratified
according to the concurrent use of enzyme-inducing anticonvulsant drugs (yes vs no).
- Phase I: Patients receive oral gimatecan 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 gimatecan 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.
- Phase II: Patients receive gimatecan as in phase I at the MTD. Patients are followed
for at least 1 month and then every 2 months thereafter.
PROJECTED ACCRUAL: Approximately 30-83 patients (30-42 for phase I [15-21 per stratum] and
21-41 for phase II) will be accrued for this study within 24 months.
;
Masking: Open Label, Primary Purpose: Treatment
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