Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT01019434
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed (by open brain biopsy or from a neurosurgical resection of the tumor) supratentorial glioblastoma multiforme (GBM)
* WHO grade IV disease
* Newly diagnosed disease
* Must provide demonstration of an unmethylated MGMT-promoter
* At least 2 weeks and no more than 6 weeks since surgery or open biopsy
* 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)
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* WBC ≥ 3.0 x 10\^9/L
* Absolute neutrophil count ≥ 1.5 x10\^9/L
* Platelet count ≥ 75.0 x 10\^9/L
* Hemoglobin ≥ 10.0 g/dL
* Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 x ULN
* AST and/or ALT ≤ 2.5 x ULN
* Serum creatinine \< 1.5 x ULN
* PT and PTT normal
* Negative pregnancy test
* Not pregnant or nursing
* Fertile patients must use highly effective contraception
* No ischemic heart disease in the past 6 months
* 12-lead ECG normal
* No history of stroke
* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer (with no subsequent evidence of recurrence)
* No serious concurrent systemic disorder including any of the following that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol:
* Active infection
* HIV infection
* Cardiac disease
* QTc prolongation \> 450/470 msec (males/females)
* No patients with a congenital long-QT-syndrome in their own or family medical history, unless eligible at the investigator's discretion
* No known hypersensitivity to the study treatment
* No known hypersensitivity to antihistamines or other medical reason that prohibits the intake of antihistamines
* No current alcohol dependence or drug abuse
* No legal incapacity or limited legal capacity
* Able to undergo a gadolinium-enhanced MRI of the brain
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior and no concurrent investigational agent
* No prior stereotactic biopsy
* At least 30 days since prior drug therapy that has not received regulatory approval for any indication
* No chemotherapy within the past 5 years
* No prior chemotherapy for a brain tumor
* No prior radiotherapy to the head
* No other concurrent anticancer therapy
* No concurrent anticoagulation therapy except low-dose prophylactic low molecular weight heparin
* Concurrent steroid therapy allowed provided patient is on a stable or decreasing dose for ≥ 1 week
* At least 14 days since prior and no concurrent enzyme-inducing anticonvulsants (e.g., carbamazepine, phenobarbital, and phenytoin)
* No concurrent strong inducers or inhibitors of CYP3A4
* No concurrent planned surgery for other diseases (e.g., dental extraction)
* No placement of Gliadel® wafer during prior surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT01019434
Study Brief:
Protocol Section:
NCT01019434