Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I/II, Open-Label, Non-Randomized, Multicenter, Single Agent Study Of Intravenous SDX-102 For The Treatment Of Patients With MTAP-Deficient High Grade Recurrent Malignant Gliomas
RATIONALE: Drugs used in chemotherapy, such as alanosine, use different ways to stop tumor
cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of alanosine in
treating patients with high-grade progressive or recurrent malignant gliomas.
OBJECTIVES:
- Determine the maximum tolerated dose of alanosine (SDX-102) with or without
enzyme-inducible antiepileptic drugs (EIAEDs) in patients with methylthioadenosine
phosphorylase (MTAP)-deficient high-grade progressive or recurrent malignant gliomas.
- Determine the pharmacokinetics of this drug administered concurrently with EIAEDs in
these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study. Patients
are stratified according to concurrent anticonvulsant drug use (drugs that induce hepatic
metabolic enzymes vs drugs that cause modest or no induction of hepatic metabolic enzymes OR
no anticonvulsant drug).
Patients receive alanosine (SDX-102) IV continuously for 5 days. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SDX-102 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.
After completion of study therapy, patients are followed at 1 week and then every 2 months
thereafter.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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