Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01009866 : Study of Immunotoxin, MR1-1
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01009866      |      Link to official Clinicaltrials.gov listing
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