Spots Global Cancer Trial Database for Terameprocol in Treating Patients With Recurrent High Grade Glioma
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Trial Identification
Brief Title: Terameprocol in Treating Patients With Recurrent High Grade Glioma
Official Title: Phase 1 Dose Escalation and Drug Distribution Study of Oral Terameprocol in Patients With Recurrent High Grade Glioma
Study ID: NCT02575794
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UAB Comprehensive Cancer Center, Birmingham, Alabama, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Abrams Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Contact Details
Name: Manmeet Ahluwalia, MD
Affiliation: ABTC
Role: PRINCIPAL_INVESTIGATOR
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