MBM-02 (Tempol) for the Treatment of Glioblastoma Multiforme (GBM)

This is an interventional treatment trial for Glioblastoma Read More

Inclusion Criteria:

1. Be > 35 and ≤ 75 years of age;
2. Be newly diagnosed with glioblastoma multiforme within 4 weeks of open biopsy/resection;
3. Be histologically confirmed to have definitive GBM by partial or complete surgical resection (i.e. not by biopsy only) within 4 weeks prior to MBM-02 administration;
4. Have recovered from the effects of surgery, post-operative infection, and other complications before study registration;
5. Have a diagnostic contrast-enhanced MRI or CT scan of the brain performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days prior to MBM-02 administration;
6. If female and of child bearing potential, must be using an effective birth-control method as described in section 3.5;
7. If a male with a female partner of child bearing potential, adequate methods of contraception must be employed as described in section 3.5.
8. If male, no sperm donation for 90 days until after the conclusion of the study;
9. Be properly informed of the nature and risks of the clinical investigation, comply with all clinical investigation-related procedures, and sign an Informed Consent Form prior to entering the clinical investigation;
10. Be able to participate for the full term of the clinical investigation;
11. Have a Karnofsky performance status of >70;
12. Have a life expectancy ≥ 6 months; and
13. Have adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):

Hematology:

Absolute neutrophil count (ANC) ≥1.5 Hemoglobin ≥ 10 g/dL Platelets ≥ 100,000 per microliter of blood

Hepatic:

Total bilirubin ≤ 2 x ULN Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2 x ULN

Renal:

creatinine clearance (CrCl) ≥ 60 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CrCl female = 0.85 x (CrCl male)

Exclusion Criteria:

1. Evidence of recurrent GBM or metastases detected outside of the cranial vault;
2. Patients with histone H3 K27M mutation or gliosarcoma;
3. Patients using the Optune device during study drug administration;
4. Prior cancer diagnosis other than skin basal cell or squamous cell carcinoma (non-metastatic);
5. Patients unable to undergo MRI because of non-compatible devices;
6. Oxygen dependent chronic obstructive pulmonary disease (COPD);
7. Unstable coronary artery disease (CAD);
8. Diagnosis of midline diffuse glioma (glioblastoma);
9. Insufficient biopsy tissue for full molecular profiling of the tumor;
10. Prior radiation or chemotherapy for glioblastoma or glioma;
11. Prior radiation for cancer of the head and neck that would result in an overlap of radiation fields;
12. Evidence of a significant medical illness, or a psychiatric illness/social situation that would, in the investigator's judgment, make the patient inappropriate for this study;
13. Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption of the study drug;
14. Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation;
15. Have used an investigational drug within 28 days of the initiation of study treatment;
16. Have a history of a positive blood test for HIV;
17. At the time of screening, have a significant active medical illness which, in the opinion of the investigator, would preclude completion of the study; and
18. Body weight less than 35 kg (77 lbs.)