Terameprocol in Treating Patients With Recurrent High Grade Glioma

Completed · Phase 1

Conditions studied: High Grade Glioma (III or IV)

In brief

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.

Key facts

Study ID: NCT02575794
Run by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
People needed: 20
Starts: 2018-05-03
Expected to finish: 2023-10-04
Last updated by the study team: 2023-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically confirmed supratentorial high grade glioma (grade III or IV glioma) that is progressive or recurrent following radiation therapy and chemotherapy; patients with grade IV glioma must have progressed or recurred after initial treatment with radiation and temozolomide; patients with grade III glioma must have received at least radiation and one regimen of chemotherapy (temozolomide or procarbazine, lomustine, vincristine [PCV] regimen)
Patients must have measurable contrast-enhancing disease by magnetic resonance imaging (MRI) imaging within 21 days of starting treatment; patient must be able to undergo MRI of the brain with gadolinium
Patients may have had treatment for an unlimited number of prior relapses
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:
12 weeks from the completion of radiation
6 weeks from a nitrosourea chemotherapy
3 weeks from a non-nitrosourea chemotherapy
4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents
2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.)
4 weeks from prior antiangiogenesis therapy (approved or investigational) (e.g., bevacizumab, aflibercept, ramucirumab, cediranib, cabozantinib, etc.)
Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
Patients must be 18 years of age or older
Absolute neutrophil count >= 1,500/mcL
Platelets >= 100,000/mcL
Hemoglobin >= 9 g/dL
Total bilirubin =< institutional upper limit of normal
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal
Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60 ml/min/1.73 m\^2 for patients with creatinine levels above institutional normal
Activated partial thromboplastin time (APTT)/partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal
Patients must be able to provide written informed consent
Women of childbearing potential must have a negative serum pregnancy test prior to study entry; women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 30 days after the last dose of study drug; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug
Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five years
Patients must be able to swallow oral medications
Part 2 (surgical) patients only: patients must be undergoing surgery that is clinically indicated as determined by their care providers; patients must be eligible for surgical resection according to the following criteria:
Expectation that the surgeon is able to resect at least 100 mg of tumor from enhancing tumor and at least 100 mg from non-enhancing tumor with low risk of inducing neurological injury

You may not qualify if…

Patients receiving any other investigational agents are ineligible
Patient must not have known sensitivity to terameprocol or any formulation excipients
Patients with (mean of triplicate) QTc(F) >/= 450mS on screening 12-lead triplicate electrocardiogram (ECG) are ineligible
Patients must not be on any anticoagulation
Patients on any moderate or strong cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9) inducer (e.g., carbamazepine, rifampin) or inhibitor (e.g., amiodarone, fluconazole) are ineligible; CYP2C9 poor metabolizers will not be excluded
Patients on narrow-therapeutic drugs that are substrates for cytochrome P450 family 1, subfamily A, polypeptide 2 (CYP1A2), CYP2C9, cytochrome P450 family 2, subfamily C, polypeptide 19 (CYP2C19), and cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, phenytoin, pimozide, quinidine, sirolimus, tacrolimus, theophylline, tizanidine, warfarin)
Patient must not have prior gastrointestinal (GI) surgery or GI disease that might interfere with the absorption of terameprocol
Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible
Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with terameprocol
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy

Where it is running

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

Full record on ClinicalTrials.gov

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