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Terameprocol in Treating Patients With Recurrent High Grade Glioma
Phase 1
Waitlist Available
Led By Manmeet Ahluwalia, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 - day28 (first cycle)
Awards & highlights
No Placebo-Only Group
Summary
This trial studies the best dose and side effects of terameprocol in patients with recurring high-grade glioma. Terameprocol is a chemotherapy drug that aims to stop cancer cells from growing, dividing, or spreading.
Eligible Conditions
- Brain Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 - day28 (first cycle)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 - day28 (first cycle)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in terameprocol tumor to plasma concentration ratio (Part 2)
Maximum tolerated days of terameprocol dosing that can safely be administered on a continuous basis (Part 3)
Maximum tolerated dose of terameprocol (Part 1)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (terameprocol)Experimental Treatment2 Interventions
Patients receive terameprocol PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Pharmacological Study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Terameprocol
2018
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
571 Previous Clinical Trials
33,334 Total Patients Enrolled
Erimos PharmaceuticalsIndustry Sponsor
5 Previous Clinical Trials
84 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,067 Total Patients Enrolled
Manmeet Ahluwalia, MDPrincipal InvestigatorABTC
6 Previous Clinical Trials
400 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot participate if you are already taking any other experimental medications.You have received nitrosourea chemotherapy within the past 6 weeks.You have received a type of chemotherapy other than nitrosourea within the past 3 weeks.The surgeon should be able to remove a certain amount of tumor during surgery without causing harm to the brain.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (terameprocol)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.