Phase I Trial of Intratumoral Injection of DTI-015 for Recurrent Malignant Gliomas
This study will involve 45 patients with malignant glioma brain tumors. Before the study,
all patients will be given a physical exam and blood and urine tests, and they will be asked
about their cancer and treatment. A magnetic resonance imaging (MRI) scan of the brain will
pinpoint the location of the tumor. Female patients who are able to have children will have
a pregnancy test. All patients will be asked about their quality of life and will undergo
tests of their mental functions. Patients might receive a steroid drug for several days
before and after the treatment. This will help prevent swelling around the tumor. Patients
will also be given a drug to prevent convulsions.
DTI-015 will be injected through a catheter (a hollow tube) into the center of the brain
tumor. For patients undergoing a needle biopsy, computer ("stereotactic") guidance will be
used to place the catheter. For patients undergoing an open brain operation, the catheter
will be placed under the direct vision of the surgeon or with computer guidance. It is
possible that the injection might not be done in the brain operation patients because there
either is too much or too little tumor after the resection. The catheter will be removed
after the injection.
Each patient will receive only one injection although one of the first three patients might
receive a second injection if the first injection volume was less than 25% of the tumor
volume. A second injection can also be given to those patients who were stable after the
first injection and develop a nodule of growth. If >250 mg BCNU total was injected, any
repeat injection cannot be done for at least 6 weeks. The dose of DTI-015 will depend on
the size of the patient's tumor. The dose level will be increased after the first 3
patients and again after the next 3 patients. After the treatment, the patient will remain
in the hospital for 1 day.
Several tests will be repeated during the study. Patients will come to M.D. Anderson every
2-4 weeks for a total of 12 weeks. Blood tests will be done during each visit. An MRI scan
of the brain will be done every month for 3 months. The physical exam, quality of life
questionnaire, and mental functions tests will be repeated 12 weeks after the treatment.
Some blood tests, however, may be done by a local doctor. The test results would then be
sent to the study coordinator. The follow-up visits will end after 12 weeks.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Dose of DTI-015
Every 2-4 weeks
Samuel J. Hassenbusch, MD, PHD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|