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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT01582269
Eligibility Criteria:
Inclusion Criteria:
* Histological confirmed diagnosis of relapsed intracranial GB
* Progressive Disease (PD) following standard chemoradiation
* Prior surgical resection allowed
* Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Adequate hematologic, hepatic and renal function
* Discontinued all prior cancer treatments for cancer \& recovered from the acute effects of therapy
* Tumor specimen must be available for a central pathology review and prognostic and predictive biomarker evaluation
Exclusion Criteria:
* Moderate or severe heart disease based on New York Heart Association (NYHA) criteria
* Prior nitrosurea therapy (including lomustine or Gliadel)
* Prior bevacizumab as 1st line treatment for GB (if treatment was concluded 12 months prior to enrollment, the patient may be eligible to participate in the trial)
* Current acute or chronic myelogenous leukemia
* Second primary malignancy that may affect the interpretation of results
* Serious concomitant systemic disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01582269
Study Brief:
Protocol Section:
NCT01582269