Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038441
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2002-05-30
Brief Title:
Phase I Trial of Intramural Injection of DTI-015 for Recurrent Malignant Gliomas
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Trial of Intratumoral Injection of DTI-015 for Recurrent Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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 patients 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 MD 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
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 patients 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 MD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None