| Titre |
A Phase II Study in Relapsing Glioblastoma of Intraarterial Concurrent Chemoradiation Therapy Using IA Carboplatin |
| Protocole ID |
2018-2452 |
| ClinicalTrials.gov ID |
NCT03672721 |
| Type(s) de cancer |
Cerveau (SNC) |
| Phase |
Phase II |
| Stade |
Récidive |
| Type étude |
Traitement |
| Médicament |
Carboplatine |
| Institution |
CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
 HOPITAL FLEURIMONT
3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
|
| Ville |
Sherbrooke |
| Investigateur(trice) principal(e) |
Dr David Fortin
|
| Coordonnateur(trice) |
Marie-Andrée Roy
819-346-1110 poste 13895
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Histological diagnosis of glioblastoma multiforme
- Radiological progression on an MRI scan, according to the RANO criteria, in the context of a known glioblastoma multiforme, already treated with the Stupp protocol of combined radiotherapy-Temozolomide, and progressing. This implies a measurable disease on MRI.
- Prior radiotherapy and temozolomide, as per the Stupp protocol, no sooner than 4 weeks, is permitted.
- 18 of age and over
- Performance status: Karnofsky 60-100%
-
Haematopoietic parameters at enrolment:
- Platelet counts > 100,000/mm^3
- Hemoglobin > 8 g/dL
- Absolute neutrophil count > 1,500/mm^3
- No impaired bone marrow function
-
Hepatic parameters at enrolment:
- Bilirubin ≤ 2 times normal value
- AST and ALT ≤ 2 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN (unless attributed to tumor)
- No impaired hepatic function
-
Renal parameters at enrollment:
- No impaired renal function
- Creatinine no greater than 1.5 fold of the normal value
- Creatinine clearance > 30 ml/min.
- Normal ECG
- Written informed consent obtained
-
Patient should be either sterile or else use a contraceptive strategy (for at least 2 months prior to study accrual).
|
| Critètes d'exclusion |
- Presence of a severe psychiatric or medical condition that would interfere with treatment administration or study enrolment.
- Presence of an active auto-immune disease.
- Occurrence of another malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Pregnancy (as objectivated by a positive b-HCG) or actively nursing
- Presence of an uncontrolled systemic infection
|
Groupe d'étude en oncologie du Québec