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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT00669669
Eligibility Criteria:
Inclusion Criteria:
* Patients with glioblastoma multiforme or gliosarcoma
* The patient or legal guardian must be able to comprehend the informed consent form and sign prior to patient enrollment
* Karnofsky performance status at time of study entry must be \>= 70%
* Life expectancy of \>= 3 months
* Patients must agree to undergo repeat clinical neurological examinations and brain magnetic resonance imaging (MRI) with appropriate contrast after every other cycle of chemotherapy
* White blood cell (WBC) \> 3000/ul
* Absolute neutrophil count (ANC) \> 1500/ul
* Platelets \> 100,000/ul
* Hemoglobin \> 10 gm/100ml
* Total and direct bilirubin \< 1.5 times upper limit of laboratory normal
* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =\< 3 times upper limit of laboratory normal
* Alkaline phosphatase =\< 3 times upper limit of laboratory normal
* Blood urea nitrogen (BUN) \< 1.5 times upper limit of laboratory normal
* Serum creatinine \< 1.5 times upper limit of laboratory normal
* Left ventricular ejection fraction (LVEF) \>= 40%, however, subjects with a LVEF in the range of 40-49% should have cardiology clearance prior to intervention
* MGMT promoter methylation analysis of surgically resected tumor or tumor biopsy must demonstrate an unmethylated or hypomethylated MGMT promoter status
Exclusion Criteria:
* Patients with cardiac insufficiency and a LVEF of \< 40%; history of coronary artery disease or arrhythmia, which has required or requires ongoing treatment
* Patients with active pulmonary infection and/or pulse oximetry \< 90% and a corrected diffusion capacity of the lung for carbon monoxide (DLCO) \< 70% of predicted
* Active systemic infection
* Patients who are human immunodeficiency virus (HIV) positive
* Pregnant or lactating women; a beta-human chorionic gonadotropin (HCG) level will be obtained from women of childbearing potential; fertile men and women should use effective contraception
* Previous chemotherapy for any malignancy including temozolomide, dacarbazine (DTIC) or prior nitrosourea
* Diabetes mellitus
* Bleeding disorder
* Methylated or hypermethylated MGMT promoter status within tumor tissue
* Medical or psychiatric condition which in the opinion of the protocol chairman would compromise the patient's ability to tolerate this protocol
* Prior interstitial radiotherapy, stereotactic or gamma knife surgery or implanted BCNU-wafers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00669669
Study Brief:
Protocol Section:
NCT00669669