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Phase I Study of Immunotoxin, MR1-1


Phase 1
18 Years
N/A
Not Enrolling
Both
Supratentorial Malignant Brain Tumor

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Trial Information

Phase I Study of Immunotoxin, MR1-1


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose and dose limiting toxicity

Outcome Time Frame:

continual

Safety Issue:

Yes

Principal Investigator

Annick Desjardins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System

Authority:

United States: Food and Drug Administration

Study ID:

Pro00011617

NCT ID:

NCT01009866

Start Date:

November 2006

Completion Date:

June 2014

Related Keywords:

  • Supratentorial Malignant Brain Tumor
  • Malignant brain tumor
  • GBM
  • recurrent brain tumor
  • Supratentorial malignant brain tumor
  • astrocytomas
  • ependymomas
  • Supratentorial Malignant Brain Tumor
  • Residual, progressive, or recurrent supratentorial malignant brain tumor based on imaging studies with measurable
  • disease (>0.5cm).
  • Brain Neoplasms

Name

Location

Duke University Health System Durham, North Carolina  27705