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 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT01792505
Eligibility Criteria:
Inclusion Criteria:
* Patients must have a histopathological diagnosis of malignant glioma.
* Patients 18 years of age or older.
* Patients must have undergone maximal surgical resection of malignant glioma
* Both male and female of childbearing age entering the protocol must use a medically accepted form of birth control during the study, will be required to have a negative pregnancy test for female.
* Patients must have a Karnofsky performance score of at least 60%.
* Patients must be off steroids for at least two weeks prior to vaccination.
* Baseline hematologic and complete metabolic panel within one week of initiating therapy must fall within normal ranges
* Patient must be capable of signing IRB approved Research Consent and Release of Medical Records form.
Exclusion Criteria:
* Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk.
* The presence of an acute infection requiring active treatment will be criteria for delay or exclusion.
* Contraindication to MRI procedure unless otherwise determined by PI.
* Patients with a known history of an autoimmune disorder.
* Pregnancy.
* Patients positive for hepatitis B, hepatitis C, HIV I/II, syphilis, HTLV I/II, HCV.
* Patients with allergy to Gentamicin.
* Patient inability to participate as determined by PI discretion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01792505
Study Brief:
Protocol Section:
NCT01792505