Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I/II Trial Of CCI-779 In Patients With Malignant Glioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of CCI-779 in treating patients who have
malignant glioma.
OBJECTIVES:
- Determine the maximum tolerated dose of CCI-779 in patients with malignant glioma.
- Determine the safety profile of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the efficacy of this drug, in terms of survival and objective response, in
these patients.
OUTLINE: This is a dose-escalation study. Patients in phase II are stratified according to
use of enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no) and disease type
(glioblastoma multiforme with stable neuro-imaging after radiotherapy vs recurrent malignant
glioma). Patients in phase I must be currently receiving EIAEDs.
- Phase I: Patients receive CCI-779 IV over 30 minutes once weekly. Treatment repeats
every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CCI-779 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 CCI-779 as in Phase I. Patients who are candidates for
surgical resection of recurrent disease receive CCI-779 IV over 30 minutes 2 hours prior
to surgery and then once weekly, as above, once recovered from surgery.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of this study within 12
months. A total of 87 patients will be accrued for phase II of this study within 12 months.
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