Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372515
Status:
COMPLETED
Last Update Posted:
2018-01-31
First Post:
2006-09-06
Brief Title:
High Dose Gefitinib for the Treatment of Carcinomatous Meningitis in Adult Patients With Non-Small Cell Lung Cancer and Known or Suspected EGFR Mutations
Sponsor:
David M Jackman MD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase I Study of High Dose Gefitinib Iressa for the Treatment of Carcinomatous Meningitis in Adult Patients With Non-Small Cell Lung Cancer and Known or Suspected EGFR Mutations
Status:
COMPLETED
Status Verified Date:
2018-01
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:
The primary purposes of this study are to find out if using high doses of the drug Gefitinib Iressa as a way to treat patients with non-small cell lung cancer that has spread to the covering of the brain andor spinal cord meninges results in any bad side effects and to determine the highest dose that can be given to patients in this setting
Detailed Description:
The standard therapy for this type of cancer is to give chemotherapy directly into the spinal fluid usually by a spinal tap Some chemotherapy may in some cases be combined with radiation This study looks at a different way of treating this type of cancer
This study is specifically for patients whose lung cancer has changes in a protein called the epidermal growth factor receptor EGFR The study drug gefitinib was developed to stop the signals from the EGFR that tell certain types of lung cancers tumors to grow By using higher doses than are normally used we hope to increase the amount of drug in the spinal fluid to attempt to kill the cancer cells around the spinal cord and brain
Since we are looking for the highest dose of gefitinib that can be given safely not everyone who participates in this study will be receiving the same amount of drug
Patients will start taking gefitinib daily by mouth on Day 1 and will continue taking this medication daily at home On the first day the patient takes gefitinib and on Day 14 of each treatment cycle 1 cycle equals 28 days the patient will undergo Physical examination by the study doctor and a detailed neurological exam by a neuro-oncologist sampling of cerebrospinal fluid CSF by lumbar puncture review of current medications measurement of vital signs check on the patients ability to perform daily activities blood work
If the patient is tolerating the study medication well then the patient will receive a lower dose for days 15-28 of the cycle
At the end of each cycle on Day 28 the patient will meet with the study doctor and have the following a physical examination review of current medications measurement of vital signs check on the patients ability to perform daily activities blood tests MRI of the brain and spinal cord to assess tumor response every two cycles a CT scan of the chest and abdomen to assess the tumor response
This study is specifically for patients whose lung cancer has changes in a protein called the epidermal growth factor receptor EGFR The study drug gefitinib was developed to stop the signals from the EGFR that tell certain types of lung cancers tumors to grow By using higher doses than are normally used we hope to increase the amount of drug in the spinal fluid to attempt to kill the cancer cells around the spinal cord and brain
Since we are looking for the highest dose of gefitinib that can be given safely not everyone who participates in this study will be receiving the same amount of drug
Patients will start taking gefitinib daily by mouth on Day 1 and will continue taking this medication daily at home On the first day the patient takes gefitinib and on Day 14 of each treatment cycle 1 cycle equals 28 days the patient will undergo Physical examination by the study doctor and a detailed neurological exam by a neuro-oncologist sampling of cerebrospinal fluid CSF by lumbar puncture review of current medications measurement of vital signs check on the patients ability to perform daily activities blood work
If the patient is tolerating the study medication well then the patient will receive a lower dose for days 15-28 of the cycle
At the end of each cycle on Day 28 the patient will meet with the study doctor and have the following a physical examination review of current medications measurement of vital signs check on the patients ability to perform daily activities blood tests MRI of the brain and spinal cord to assess tumor response every two cycles a CT scan of the chest and abdomen to assess the tumor response
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