Mebendazole in Newly Diagnosed High-Grade Glioma Patients Receiving Temozolomide

• Status: Completed
• Trial end date: 2021-04-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find the highest dose of mebendazole (MBZ) that can be safely given to people with malignant brain tumors in combination with the current standard of care (temozolomide) without causing severe side effects. We also want to find out if MBZ can slow the growth of the brain tumor. The study doctors have found that MBZ is effective against malignant brain tumors in the laboratory and animal models of brain tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Accelerate Brain Cancer Cure
• Treatments: DMP 777; Mebendazole; Piperazine; Piperazine citrate; Temozolomide

Criteria

Inclusion Criteria:

1. Patients must have histologically confirmed newly diagnosed high-grade glioma(WHO Grade III or IV)

2. Age ≥18 years

3. Karnofsky Performance Score (KPS) ≥ 60%

4. Life expectancy greater than 12 weeks

5. Patients must have adequate organ and marrow function

6. Completed >80% of the prescribed radiation therapy and concurrent temozolomide according to the Stupp regimen without grade 3 or 4 hematologic toxicity

7. Patients may have received Gliadel during surgery

8. Ability to swallow pills and keep medication record

9. women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation.

10. Ability to understand and willingness to sign a written informed consent document

11. Be able to comply with treatment plan, study procedures and follow-up examinations

Exclusion Criteria:

1. Patients must not have received prior therapy other than standard chemoradiation according to Stupp et al and Gliadel.

2. Patients may not be receiving any other investigational agents while on study

3. Patients who have known allergy to mebendazole or benzimidazole

4. Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for a parasitic infection

5. Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapy

6. Patients who have taken any benzimidazole (ABZ, flubendazole, thiabendazole, fenbendazole, triclabendazole, etc.) within the last 3 months

7. Patients who are taking any anti-convulsant medication that interferes with the cytochrome P450 pathway (e.g. phenytoin, phenobarbital, carbamazepine, etc.)

8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, chronic hepatitis, acute hepatitis, or psychiatric illness/social situation that would limit compliance with study requirements

9. Pregnant women are excluded

10. Patients with human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C positive; or with a history of chronic active hepatitis or cirrhosis

11. Patients with a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product administration or may interfere with the interpretation of the results

12. Patients who are not available for follow-up assessments or unable to comply with study requirements