| Titre |
Metformin and Neo-adjuvant Temozolomide and Hypofractionated Accelerated Limited-margin Radiotherapy Followed by Adjuvant Temozolomide in Patients With Glioblastoma Multiforme |
| Protocole ID |
MUHC ID: 4315 (M-HARTT STUDY) |
| ClinicalTrials.gov ID |
NCT02780024 |
| Type(s) de cancer |
Cerveau (SNC) |
| Phase |
Phase II |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr George Shenouda
|
| Coordonnateur(trice) |
Marianna Perna
514-934-1934 poste 43191
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Age: 18 years or older
- Histological confirmation of supra-tentorial GBM
- KPS > 60
- Neurological function 0 or 1
- Adequate bone marrow as defined below:
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3. Platelets ≥ 100,000 cells/mm3 Hemoglobin ≥ 10 g/dl.
- Adequate renal function, as defined below:
- Creatinine clearance of >60 ml/min/1.73m2 (using the Cockcroft Gault equation for eGFR) within 14 days prior to study registration
- Adequate hepatic function, as defined below:
- Bilirubin of 1.7 to 18.9 umol/L within 14 days prior to study registration
- ALT ≤ 3 x normal range within 14 days prior to study registration
- Neo-adjuvant TMZ and Metformin to start within 4 weeks of surgery
- Concomitant TMZ and Metformin and accelerated Hypofractionated EBRT to start at least 2 weeks after adjuvant TMZ starting date, and no later than five weeks from surgery.
- Surgical diagnosis/intervention may include: partial or near total resection
- Patients must have recovered from the effects of surgery, postoperative infection and other complications before study registration.
- A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively. The postoperative scan must be done within 28 days prior to the initiation of neo-adjuvant TMZ. Preoperative and postoperative scans must be the same type. Patients unable to undergo MR imaging can be enrolled provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality.
- History/physical examination, including neurologic exam within 14 days prior to study registration.
- Documentation of steroid doses within 14 days prior to study registration and stable or decreasing steroid dose within 5 days prior to registration.
- For females of child-bearing potential, negative serum pregnancy test within 72hours prior to starting TMZ and Metformin. Women of childbearing potential and male participants must practice adequate contraception.
- Adequate tissue specimen for MGMT status analysis.
- Able to sign an informed study-specific consent
|
| Critètes d'exclusion |
- Diabetic patients both type I and type II.
- No tissue provided for MGMT promoter methylation status determination.
- Margin of contrast-enhanced residual mass closer than 15 mm from the optic chiasm or optic nerves.
- Prior invasive malignancy (except for non-melanoma skin cancer) unless disease free for ≥ 3 years
- Recurrent or multifocal GBM.
- Prior chemotherapy or radio-sensitizers for cancers of the head and neck region; prior chemotherapy for a different cancer is allowable.
-
Severe, active co-morbidity, defined as follows:
- Acute or chronic renal failure.
- Unstable angina and/or congestive heart failure requiring hospitalization
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition.
- Major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Pregnant or lactating women, due to possible adverse effects on the developing foetus or infant due to study drug.
- Prior allergic reaction to Temozolomide or Metformin.
- Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study
|
Groupe d'étude en oncologie du Québec