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 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT00431561
Eligibility Criteria:
Inclusion Criteria:
* Histopathologically confirmed diagnosis of recurrent or refractory high-grade glioma (anaplastic astrocytoma, WHO grade III; or glioblastoma, WHO grade IV)
* Supratentorial localization
* No more than two chemotherapy regimens including radiochemotherapy since primary diagnosis
* Eligible for either TMZ or PCV treatment
* Recovery from acute toxicity caused by any previous therapy
* Adequate organ functions
* KPS at least 70%
Exclusion Criteria:
* Tumor surgery within 2 weeks prior to study entry
* Radiation therapy within 8 weeks prior to study entry
* Chemotherapy within 4 weeks prior to study entry (nitrosureas: 6 weeks)
* No more than 3 mg/day dexamethasone (or equivalent) at baseline
* Prior TGF-beta targeted therapy or tumor vaccination
* Baseline MRI shows mass effect
* Known active infection with HIV, HBV, or HCV; acute viral, bacterial, or fungal infection
* Significant psychiatric disorders/legal incapacity or a limited legal capacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00431561
Study Brief:
Protocol Section:
NCT00431561