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:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT01233492
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Radiologically and clinically suspected solitary glioblastoma multiforme
* High-grade disease
* Agreed to undergo stereotactic biopsy as part of routine diagnostic work-up
PATIENT CHARACTERISTICS:
* WHO performance status 0-2 (0-1 for patients ≥ 65 years old)
* Life expectancy \> 4 months
* Hemoglobin ≥ 9.0 g/dL
* Neutrophil count ≥ 1.5 x 10\^9/L
* Platelet count ≥ 100 x 10\^9/L
* Serum bilirubin ≤ 1.5 times upper normal of limit (ULN)
* AST ≤ 1.5 times ULN
* Uncorrected EDTA-Isotope creatinine clearance ≥ 40 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use two forms of effective contraception 4 weeks prior to, during, and for 6 months after completion of study therapy
* Able to cooperate with procedures and follow-up
* Not at high risk of complications from blood-brain barrier disruption with mannitol on pre-treatment CT scan (an open quadrigeminal plate cistern, absence of dilatation of the contralateral frontal horn, and absence of uncal herniation)
* No history of uncontrolled seizures
* No phenylketonuria
* No current or previous malignancies at sites other than the brain, except for adequately treated cone-biopsied carcinoma in-situ of the uterine cervix or basal cell or squamous cell carcinoma of the skin
* Not at high medical risk due to nonmalignant systemic disease, including active uncontrolled infection
* No known hepatitis B, hepatitis C, or HIV positivity by serology
* No concurrent congestive heart failure, history of NYHA class III-IV cardiac disease, history of myocardial infarction or active ischemic heart disease within the past year, or history of cardiac arrhythmia or thromboembolic disease
* No other condition that, in the investigator's opinion, would not make the patient a good candidate for the clinical trial
PRIOR CONCURRENT THERAPY:
* At least 12 hours since prior and no concurrent steroids
* At least 48 hours since prior phenylalanine-containing drinks (e.g., colas)
* At least 48 hours since prior excessive consumption of phenylalanine-containing foods, including any of the following:
* Low phenylalanine content (e.g., fruit juice, fruits \[except bananas\], vegetables, and low-protein breads and pastas
* Medium phenylalanine content (e.g., corn, bread, french fries, potatoes, peas, rice, and regular pasta)
* High phenylalanine content (e.g., refried beans, chicken, nuts, hamburgers, peanuts, cheese, eggs, pork chops, steak, bananas, and milk)
* At least 4 weeks since prior major thoracic and/or abdominal surgery and recovered
* No prior cranial radiotherapy
* No prior endocrine therapy, immunotherapy, or chemotherapy for the brain tumor
* No other concurrent anticancer therapy or investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT01233492
Study Brief:
Protocol Section:
NCT01233492