Phase I Trial of Intramural Injection of DTI-015 for Recurrent Malignant Gliomas
Condition: Glioma; Brain Neoplasms
MeSH terms: Glioma; Brain Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a clinical research study of a new investigational treatment for cancer called
      "DTI-015" to be given by intratumoral injection. Intratumoral injection is when drug is
      injected directly into the tumor. This study will help doctors find out what is the best dose
      level for DTI-015 and if this treatment can shrink tumors without causing severe side
      effects. The effects of the drug on the patient's quality of life (how the patient feels and
      what the patient can do) and their mental functions (reasoning and thinking abilities) will
      also be studied.
    

Detailed description: 
      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.
    

Intervention name(s): DTI-015
Intervention type(s): Drug
Intervention description(s): DTI-015 injected through a catheter into center of brain tumor.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malignant Glioma