Phase
Condition
Gliomas
Glioblastoma Multiforme
Astrocytoma
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Newly diagnosed histologically-confirmed supra-tentorial GBM (World HealthOrganization grade IV) patients. Whenever feasible, patients will undergo maximalsurgical resection or debulking, although patients with inoperable glioblastomas arealso eligible.
Progression-free patients after having undergone maximal safe debulking surgery whenfeasible or biopsy, and
Patients undergone completed standard concomitant chemo-radiotherapy with temozolomide
Patients with provision of signed and dated, written informed consent prior to anystudy specific procedures, sampling and analyses.
Patients (both males and females) should employ adequate contraceptive measures whichshould be maintained during the whole duration of the trial
Additional eligibility criteria include: age between 18 and 70; Karnofsky PerformanceStatus (KPS) score of 70 or higher; adequate kidney, liver, bone marrow, and cardiacfunction; total serum bilirubin level and liver- function values; isocitratedehydrogenase 1/2 (IDH1/2) mutational status; MGMT methylation status assessment.
Exclusion
Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria apply:
- Treatment with any of the following:
Any other chemotherapy, immunotherapy or anticancer agents within 4 weeks beforeenrollment in the study.
Any investigational agents or study drugs from a previous clinical study within 30 days before the first dose of study treatment.
MGMT methylated
As judged by the investigator, any evidence of severe or uncontrolled systemicdiseases, including: uncontrolled hypertension; active bleeding diatheses; activehepatitis B virus (HBV), hepatitis C virus (HCV) or HIV infection. Screening forchronic conditions is not required; inadequate bone marrow reserve or organ function,as demonstrated by laboratory parameters.
Judgment by the investigator that the patient should not participate to the study if thepatient is unlikely to comply with study procedures, restrictions and requirements.
Contraindications to MRI and or magnetic resonance spectroscopy (MRS). 6. Patients notable to sign informed consent.
Study Design
Study Description
Connect with a study center
Regina Elena Cancer Institute
Roma, Lazio 00144
ItalyActive - Recruiting
Carlo Besta Neurological Institute
Milano, Lombardia 20133
ItalyActive - Recruiting
Istituto Oncologico Veneto
Padova, Veneto 35128
ItalyActive - Recruiting
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