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:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT01205334
Eligibility Criteria:
INCLUSION CRITERIA:
* Histopathological verification of glioblastoma multiforme (GBM: WHO grade IV) in remission (Group A) or with active disease (Group B).
* CMV-positive GBM
* CMV seropositive
* Life expectancy 6 weeks or greater
* Karnofsky/Lansky score 50 or greater
* Patient or parent/guardian capable of providing informed consent
* Bilirubin less than 1.5x upper limit of normal, AST less than 3x upper limit of normal, serum creatinine less than 1.5x normal and Hgb 8.0 g/dL or greater
* Pulse oximetry of 90% or greater on room air
* Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. The male partner should use a condom.
* Patients should have been off other investigational antineoplastic therapy for one month prior to entry in this study.
* Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
EXCLUSION CRITERIA:
* Severe intercurrent infection
* Known HIV positivity
* Pregnant or lactating
* History of hypersensitivity reactions to murine protein-containing products.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01205334
Study Brief:
Protocol Section:
NCT01205334