Adult Gliosarcoma Clinical Trial
Official title:
A Phase I-II Trial of Depsipeptide in Patients With Recurrent High-Grade Gliomas
This phase I/II trial is studying the side effects and best dose of FR901228 and to see how well it works in treating patients with recurrent high-grade gliomas. FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) of FR901228 (depsipeptide) in patients with
recurrent malignant gliomas who are taking enzyme-inducing antiepileptic drugs (EIAEDs).
(Phase I) II. Determine the safety profile of this drug in these patients. (Phase I) III.
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. (Phase
I) IV. Determine the clinical efficacy of this drug, as measured by 6-month progression-free
survival and objective tumor response, in these patients. (Phase II) V. Determine the safety
profile of this drug when administered at the phase I MTD concurrently with or without
EIAEDs in these patients. (Phase II)
OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II study.
Patients are stratified according to study phase (I vs II), concurrent use of
enzyme-inducing anti-epileptic drugs (EIAEDs) (yes vs no), histology (recurrent glioblastoma
multiforme/gliosarcoma vs recurrent anaplastic glioma), pre-operative candidacy (yes vs no),
and measurable/evaluable disease (yes vs no). Patients are assigned to 1 of 2 treatment
groups (group A: no EIAEDs or group B: concurrent use of EIAEDs).
Phase I (group B only): Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1,
8, and 15. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of FR901228 until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of up to 6 patients experience dose-limiting toxicity.
Phase II (groups A and B):
Group A (phase II): Patients receive FR901228 as in phase I at dose level 1. Group B (phase
II): Patients receive FR901228 as in phase I at the MTD.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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