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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT00238303
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed grade 4 astrocytoma (glioblastoma multiforme), including gliosarcoma, at primary diagnosis or recurrence
* Progressive or recurrent disease
* Measurable or evaluable disease by MRI or CT scan
* Performance status - ECOG 0-2
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8 g/dL
* AST ≤ 3 times upper limit of normal (ULN)
* Bilirubin normal
* Creatinine ≤ 1.5 times ULN
* No myocardial infarction within the past 6 months
* No congestive heart failure
* No life-threatening ventricular arrhythmia requiring ongoing maintenance therapy
* No known HIV positivity
* Not immunocompromised except if related to the use of corticosteroids
* No known hypersensitivity to any of the components of the study drug
* No uncontrolled infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* No other malignancy
* No other severe disease that would preclude study participation
* Prior adjuvant chemotherapy allowed
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* More than 2 weeks since prior small molecule cell cycle inhibitor
* Concurrent corticosteroids allowed as long as dose has been stable for ≥ 1 week
* At least 8 weeks since prior radiotherapy
* Must have evidence of tumor progression by MRI or CT scan after radiotherapy
* More than 6 weeks since prior stereotactic radiosurgery or interstitial brachytherapy, unless 1 of the following criteria is met:
* There is a separate lesion by MRI outside of the prior treatment field
* There is evidence of recurrent disease by biopsy, MRI spectroscopy, or positron-emission tomography scan
* More than 2 weeks since prior valproic acid
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00238303
Study Brief:
Protocol Section:
NCT00238303