7669-06-11R1 Immunotoxin, MR1-1

Clinical Trials for Adults | A Phase I Study of Immunotoxin, MR1-1

Purpose:

The purpose of this study is to determine if the therapeutic MR1-1KDEL, a tumor-specific immunotoxin, has an anti-tumor effect on malignant brain tumors and if so, the highest dose to safely administer. This immunotoxin binds to the tumor specific epidermal growth factor receptor mutation (EGFRvIII), which is common among many malignant gliomas, and kills the tumor cell.

This study will only take place at Duke University Medical Center.  Up to 36 patients will be enrolled.  

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
  • Patients must be at least 18 years old
  • Patients with tumors greater than 5 cm in maximum diameter are excluded

Exclusion Criteria

  • Patients who have received prior Avastin (bevacizumab) therapy
  • Patients who have received prior EGFRvIII directed immunotherapy 

Treatment Plan:

Initial Catheter Placement —Two small tubes (catheters) placed into or around the tumor with other ends extending slightly outside of the head. This will be done in the operating room. An MRI or CT scan will be done to make certain each catheter is correctly placed. This will enable the MR1-1 to go directly to the area of the tumor. Once the catheters have been inserted, they will remain in place for as long as the drug is being infused. These catheters will be used to slowly infuse the treatment into the brain.

Initial Study Drug Infusion—The MR1-1 will be infused through the catheter(s) for 96 hours. This will be done in the neurosurgical intensive care unit. A normal human serum protein, albumin, which has been radiolabeled (123I) with a very small dose of radiation, will be infused with the MR1-1 to help follow the distribution of the infusion within the brain. This will allow the doctors to observe whether the immunotoxin is going to the tumor.

After receiving the study drug and upon discharge from the hospital, patients will be required to stay within 30 minutes of Duke Hospital for 14 days.

For 52 weeks after hospital discharge, patients will be required to return to Duke University Medical Center every two months for blood draws, physical exams and other tests to evaluate tumor size and clinical status.


 





This article comes from The Preston Robert Tisch Brain Tumor Center at Duke   http://www.cancer.duke.edu/btc
The URL for this story is:   http://www.cancer.duke.edu/btc/modules/ClinicalTrials4/index.php?id=72