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Clinical Trials/EUCTR2008-003003-31-GB
EUCTR2008-003003-31-GB
Active, not recruiting
Phase 1

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 sites111 target enrollmentJuly 6, 2009
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Conditionspatients with newly diagnosed glioblastoma (GBM) without methylation of the DNA-repair enzyme O6-methylguanin-DNA-methyltransferase (MGMT) gene promoterMedDRA version: 13.1 Level: LLT Classification code 10006153 Term: Brain tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DrugsTORISEL

Overview

Phase
Phase 1
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
111
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 6, 2009
End Date
December 16, 2013
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

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)

Outcomes

Primary Outcomes

Not specified

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