Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00038441
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 1995
Completion date August 2005

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04539574 - An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors N/A
Enrolling by invitation NCT04461002 - Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Completed NCT03242824 - The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma Phase 2
Recruiting NCT04186832 - Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy N/A
Completed NCT00424554 - Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed) Phase 2
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Not yet recruiting NCT04550663 - NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors Phase 1
Completed NCT02805179 - A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma Phase 2
Terminated NCT04556929 - Enhanced Detection in Glioma Excision N/A
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Recruiting NCT06043232 - MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas
Not yet recruiting NCT06043765 - Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training N/A
Not yet recruiting NCT05025969 - Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
Completed NCT02978261 - Study of a c-Met Inhibitor PLB1001 in Patients With PTPRZ1-MET Fusion Gene Positive Recurrent High-grade Gliomas Phase 1
Completed NCT01836536 - Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients N/A
Terminated NCT01502605 - Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas Phase 1
Completed NCT01479686 - iMRI Guided Resection in Cerebral Glioma Surgery Phase 3
Completed NCT01212731 - Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study
Withdrawn NCT00985036 - Vascular Endothelial Growth Factor (VEGF) Levels in Brain Tumor Patients N/A