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 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT01009866
Eligibility Criteria:
Inclusion Criteria:
* Residual, progressive, or recurrent supratentorial malignant brain tumor based on imaging studies with measurable disease (\>0.5cm).
* Patient will have completed some form of radiation therapy prior to toxin treatment.
* Karnofsky Performance score \>70.
* The presence of the target antigen, EGFRvIII, must be identified on tumor tissue by immunohistochemistry.
* Platelet count \> 100 x 109/L; PTT and PT \< 120% of normal range.
* Creatinine \< 120% of normal range.
* Total bilirubin, SGOT, SGPT,alkaline phosphatase \< 300% of normal range.
Exclusion Criteria:
* Patients who are pregnant, breast-feeding, or unwilling to practice an effective method of birth control.
* Patients with known potentially anaphylactic allergic reactions to iodine or gadolinium-DTPA.
* Patients who cannot undergo MRI due to obesity or to having certain metal in their bodies (specifically pacemakers, infusion pumps, metal aneurysm clips, metal prostheses, joints, rods or plates).
* Patients that have not recovered from the toxic effects of prior chemotherapy and/or radiation therapy.
* Patients with an impending, life-threatening cerebral herniation syndrome.
* Patients with subependymal or CSF disease.
* Patients who are under the age of 18 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01009866
Study Brief:
Protocol Section:
NCT01009866