Mebendazole in brain tumor

Phase 1

Conditions: Health Condition 1: C719- Malignant neoplasm of brain, unspecifiedHealth Condition 2: null- Recurrent high grade glioma

Registration Number: CTRI/2018/01/011542

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Inclusion criteria

1.Participants must have recurrent glioblastoma ( for randomization in either Arm A1,B1,C1 or in Arm A2, B2, C2)

a.The diagnosis of recurrent glioblastoma could be based on any of the below mentioned features

i.Histopathological confirmation of recurrence : Defined as histopathology or FNA showing a viable glioblastoma

ii.Clinico-radiological features: Unequivocal clinical or radiological features suggesting recurrence or progression

2.Age : Any age above 18 years. No maximum age.

3.ECOG performance status <=3

4.Participants must have normal organ and marrow function as defined below:

a.Leukocytes>=2,000/mcL or ANC >= 1500/mcL

b.Platelets>=100,000/mcL

c.Total bilirubin < 1.5 Ã? institutional upper limit of normal

d.AST(SGOT)/ALT(SGPT)<=2.5 Ã? institutional upper limit of normal

e.Calculated Creatinine clearance > 30 ml/min

5.The time since last chemotherapeutic investigational treatment should be more than 3 weeks

6.The effects of mebendazole on the developing human fetus are teratogenic. Hence women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is 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 6 months after completion of protocol.

7.Both men and women of all races and ethnic groups are eligible for this trial.

8.Willing and able to comply with all study requirements, including treatment (able to swallow tablets), able to be followed up at regular intervals and/or nature of required assessments (e.g. ability to undergo video follow up)

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

Exclusion Criteria

1.Participants who had life threatening complications either during CTRT with temozolomide or during adjuvant cycles of temozolomide

2.Participants who are receiving any other investigational agents.

3.Within 4 weeks of administration of chemotherapeutic agent

4.Failure within 3 months of stopping temozolomide

5.Patients with QTc prolongation defined as QTc interval greater than 440 ms in males and 480 ms in females in view of risk of sudden cardiac death associated with use of Ondansetron.

6.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.

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

8.Uncontrolled intercurrent illness including, but not limited to, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents, inflammatory bowel disease, known hyperkalemia ( CTCAE version 4.02 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements.

9.Pregnant women and breastfeeding women are excluded from this study because temozolomide has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants. These potential risks may also apply to other agents used in this study. in this situation. In keeping with ICH E8, the pregnancy of a female subject will be reported to the IRB/EC. The female subject will receive counseling about the risks to the fetus and would be given a option of termination of pregnancy . If the female subject chooses to continue the pregnancy, then the investigator would follow her pregnancy to term (or longer if possible for developmental sequelae), so that any important safety information could be obtained.

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. The testing for the same will be done in accordance with institutional standards with accompanying pre and post test counselling according to the institutional standards.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase 1 : MTD determination of Mebendazole <br/ ><br>Phase 2 : 9 month overall survival <br/ ><br> <br/ ><br>Timepoint: 9 Months <br/ ><br> <br/ ><br>

Secondary Outcome Measures