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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT00782756
Eligibility Criteria:
Inclusion Criteria:
* Pathologic diagnosis of glioblastoma or grade IV glioma.
* Tumor volume should be less than 60 cc (approximately 5cm maximum diameter).
* Age \> or = to 18
* KPS ≥70
* Granulocyte count \>1.5 X 10 9/L
* Platelet count \>99 X 10 9/L
* SGOT \< 2.5X upper limit of normal (ULN)
* Serum creatinine \< 2X ULN
* Bilirubin \< 2X ULN
* All patients must sign written informed consent
Exclusion Criteria:
* Any prior chemotherapy, radiotherapy and biologic therapy for glioma.
* Any prior experimental therapy for glioma.
* Multicentric glioma
* Other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin).
* Serious medical or psychiatric illness that would in the opinion of the investigator interfere with the prescribed treatment.
* Pregnant or breast feeding women.
* Refusal to use effective contraception
* Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 100 mmHg)
* Prior history of hypertensive crisis or hypertensive encephalopathy
* New York Heart Association (NYHA) Grade II or greater congestive heart failure
* History of myocardial infarction or unstable angina within 12 months prior to Day 1
* History of stroke or transient ischemic attack
* Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
* History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of treatment or anticipation of need for major surgical procedure during the course of the study
* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
* History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
* Serious, non-healing wound, active ulcer, or untreated bone fracture
* Proteinuria as demonstrated by a UPC ratio ≥ 1.0 at screening
* Known hypersensitivity to any component of bevacizumab
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00782756
Study Brief:
Protocol Section:
NCT00782756