NCT02575794

Terameprocol in Treating Patients With Recurrent High Grade Glioma

Phase 1 Dose Escalation and Drug Distribution Study of Oral Terameprocol in Patients With Recurrent High Grade Glioma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: 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) SECONDARY OBJECTIVES: 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. TERTIARY OBJECTIVES: 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.

Conditions

• High Grade Glioma (III or IV)

Interventions

Type	Name	Description
DRUG	Terameprocol	Given PO
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2018-05-03
• Primary completion: 2023-09-30
• Completion: 2023-10-04
• First posted: 2015-10-15
• Last updated: 2023-10-06

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study