Radiation therapy and concurrent plus adjuvant Temsirolimus (CCI-779) versus chemo-irradiation with Temozolomide in newly diagnosed glioblastoma without methylation of the MGMT gene promoter – a randomized multicenter, open-label, Phase II study

EORTC Headquarters0 sites108 target enrollmentJuly 10, 2009

Conditionspatients with newly diagnosed glioblastoma (GBM) without methylation of the DNA-repair enzyme O6-methylguanin-DNA-methyltransferase (MGMT) gene promoter MedDRA version: 9.1Level: LLTClassification code 10006153Term: Brain tumor

DrugsTORISEL

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: patients with newly diagnosed glioblastoma (GBM) without methylation of the DNA-repair enzyme O6-methylguanin-DNA-methyltransferase (MGMT) gene promoter
Sponsor: EORTC Headquarters
Enrollment: 108
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 10, 2009

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

EORTC Headquarters

Eligibility Criteria

Inclusion Criteria

•Present with newly diagnosed histologically proven supratentorial GBM (World Health Organization (WHO) grade IV). The histological diagnosis can be obtained either from an open brain biopsy or from a neurosurgical resection of the tumor.
•Patients must be at least 18 years of age.
•Estimated life expectancy of at least 12 weeks.
•Tumor tissue specimens (paraffin\-embedded and/or frozen) from the GBM surgery or open biopsy must be available for central pathology review, MGMT status determination and exploratory analysis of PI3\-K/Akt/mTOR targets (P70S6K).
•A 25 ml EDTA blood sample is also required.
•WHO\-ECOG Performance Status of \= 2\.
•Clinically normal cardiac function without history of ischemic heart disease in the past 6 months and normal 12\-lead electrocardiogram (ECG); no history of stroke.
•Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule; those conditions should be discussed with the patient before registration in the trial.
•Patients of childbearing/ reproductive potential should use highly effective method of birth control as defined by the investigator. For example those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IDUs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on contraceptives should be addressed. Women with childbearing potential must have a negative serum pregnancy test (?\-HCG) \= 14 days prior to registration and can not be breastfeeding.
•Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria

•Patients will be excluded from the study if they meet any of the following criteria:
•Have had a prior malignancy within the last 5 years (other than adequately treated carcinoma in situ of the cervix, or non\-melanoma skin cancer, with no subsequent evidence of recurrence).
•Having undergone only a stereotactic biopsy (open biopsy is allowed as ensuring sufficient tumor tissue yield).
•Unable to undergo Gd MRI.
•Have had chemotherapy within the last 5 years
•Prior chemotherapy for a brain tumor
•Prior RT of the head
•Are receiving concurrent administration of any other antitumor therapy
•Are using enzyme inducing anti convulsivants (in particular carbamazepine, phenobarbital and phenytoine) and are unable to discontinue use of these agents. Or any other strong inducers or inhibitors of CYP3A4\.
•Planned surgery for other diseases (for example, dental extraction)