Terameprocol in Treating Patients With Recurrent High Grade Glioma
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|ClinicalTrials.gov Identifier: NCT02575794|
Recruitment Status : Recruiting
First Posted : October 15, 2015
Last Update Posted : May 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|High Grade Glioma (III or IV)||Drug: Terameprocol Other: Pharmacological Study||Phase 1|
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.
|Study Type :||Interventional|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Dose Escalation and Drug Distribution Study of Oral Terameprocol in Patients With Recurrent High Grade Glioma|
|Actual Study Start Date :||May 3, 2018|
|Estimated Primary Completion Date :||December 15, 2021|
|Estimated Study Completion Date :||December 15, 2022|
Experimental: Treatment (terameprocol)
Patients receive terameprocol PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Pharmacological Study
Other Name: Pharnacological Study
- Maximum tolerated dose of terameprocol (Part 1) [ Time Frame: Day 1 - Day28 (First Cycle) ]To estimate the MTDs in terms of clinical toxicities, a modified continual reassessment method, based on that described by Piantadosi et al. will be employed. Dose escalation will be guided by observed clinical toxicity in 3 patients per dose cohort after the initial dose.
- Change in terameprocol tumor to plasma concentration ratio (Part 2) [ Time Frame: Baseline, Pre-surgery (shortly before start of surgery - within 1hr) and post surgery (as soon as practical afer completion of surgery - approx 4 hrs) ]The tumor/plasma concentration ratio will be estimated.
- Maximum tolerated days of terameprocol dosing that can safely be administered on a continuous basis (Part 3) [ Time Frame: Up to 28 days ]This is a escalation study. The escalation is the number of continuous days that terameprocol can be given. Terameprocol dose will remain constant at a fix dose everyday.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575794
|Contact: Serena Desideri, MDemail@example.com|
|Contact: Joy Fisher, MAfirstname.lastname@example.org|
|United States, Alabama|
|UAB Comprehensive Cancer Center||Not yet recruiting|
|Birmingham, Alabama, United States, 35294-3410|
|Contact: Thiru Pillay, RN 205-934-1842 email@example.com|
|Principal Investigator: Burt Nabors, MD|
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA||Not yet recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Timothy Cloughesy, MD 310-825-5321 TCloughesy@mednet.ucla.edu|
|Principal Investigator: Timothy Cloughesy, MD|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Contact: Quinn firstname.lastname@example.org, RN 410-955-8837 email@example.com|
|Contact: Trisha Surakus 410-502-9864 firstname.lastname@example.org|
|Sub-Investigator: Matthias Holdhoff, MD|
|Principal Investigator: Stuart Grossman, MD|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Not yet recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Jennifer Barrs 617-632-6119 JenniferA_Barrs@DFCI.HARVARD.EDU|
|Principal Investigator: Patrick Wen, MD|
|United States, Michigan|
|Josephine Ford Cancer Center at Henry Ford Hospital||Recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Amy Williamson, RN email@example.com|
|Contact: Emily Krozek, MHSA Ekrozek1@hfhs.org|
|Principal Investigator: Tobias Walbert, MD|
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center||Not yet recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Clinical Trials Office 336-713-6771|
|Principal Investigator: Glenn Lesser, MD|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center||Not yet recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Cancer Center-Cares 216-444-7923|
|Sub-Investigator: David Peereboom, MD|
|United States, Pennsylvania|
|Abrams Cancer Center of the University of Pennsylvania||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Clinical Trials Office-Abrams Cancer Center 800-474-9892|
|Principal Investigator: Arati Desai, MD|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073|
|Principal Investigator: Frank Lieberman, MD|
|Principal Investigator:||Manmeet Ahluwalia, MD||ABTC|