This phase I trial studies the side effects and best dose of terameprocol in treating
patients with high-grade glioma that has come back. Drugs used in chemotherapy, such as
terameprocol, work in different ways to stop the growth of tumor cells, either by killing the
cells, by stopping them from dividing, or by stopping them from spreading.
I. To estimate the maximum tolerated dose (MTD) of terameprocol given orally on days 1-5
every 28 days in patients with high grade glioma. (Part 1)
II. To evaluate terameprocol tumor to plasma ratios in resected high grade gliomas following
5 days of oral terameprocol administration. (Part 2)
III. To assess the maximum duration of terameprocol that can be safely administered on a
continuous basis. (Part 3)
I. Characterize the plasma pharmacokinetic (PK) of oral terameprocol.
II. Evaluate the toxicities of oral terameprocol.
III. Assess progression-free survival.
IV. Estimate overall survival.
V. Assess tumor response.
I. Assess the contribution of cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9)
genotypes on the variability of oral terameprocol pharmacokinetics.
OUTLINE: This is a dose-escalation study.
Patients receive terameprocol orally (PO) once daily (QD) on days 1-5. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days, every 2 months for
2 years, and then every 6 months thereafter.
High Grade Glioma,
Clinical Study Identifier
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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