Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385853
Status:
COMPLETED
Last Update Posted:
2013-10-21
First Post:
2006-10-06
Brief Title:
PTK787ZK 222584 in Combination With Temozolomide and Radiation in Patients With Glioblastoma Taking Enzyme-Inducing Anti-Epileptic Drugs
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase I Study of PRK787ZK 222584 in Combination With Daily Temozolomide and Radiation in Patients With Newly Diagnosed Glioblastoma
Status:
COMPLETED
Status Verified Date:
2013-10
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:
PTK is an investigational new drug that has been shown in early laboratory studies to prevent the formation of new blood vessels that allow the tumor to grow These studies have shown that the study drug can potentially improve the effectiveness of additional radiation and chemotherapy With this study we would like to examine the effects of PTK when used in combination with radiation therapy and the anti-cancer drug temozolomide the standard treatment for patients with newly diagnosed glioblastoma We would also like to learn how the study drug is absorbed distributed and cleared from the body
Detailed Description:
Since we are looking for the highest dose of PTK that can be administered safely without severe or unmanageable side effects not everyone who participates will get the same dose of PTK A small group will be enrolled onto the study and given a certain dose If they tolerate it well the next small group enrolled will receive a higher dose This will continue until the highest dose that can be given without severe or unmanageable side effects is found
Participants will receive PTK twice daily along with temozolomide daily during each treatment cycle Each treatment cycle lasts 28 days
PTK will start on Day 0 of the first cycle and will be given twice daily for the 7 weeks the participant receives radiation therapy
Daily doses of temozolomide will begin on Day of the first cycle and continue until the last dose of radiation therapy in cycle 1
Each participant will receive 7 weeks of radiation therapy Radiation therapy will start on Day 5 of the first cycle and will be administered monday through friday except on holidays
When radiation stops temozolomide and PTK will be given for a maximum of 6 post-radiation cycles of study treatment During these cycles PTK and temozolomide will be given for 5 consecutive days followed by 23 days of no drugs
Tests will be performed routinely throughout the study treatment and include chest x-rays blood tests physical exams urine tests and ECG
The following procedures will be performed at the end of the study or after the participants last dose of study medication tumor assessment by MRI routine blood draws neurologicalphysical exam and medical history review
Participants will receive PTK twice daily along with temozolomide daily during each treatment cycle Each treatment cycle lasts 28 days
PTK will start on Day 0 of the first cycle and will be given twice daily for the 7 weeks the participant receives radiation therapy
Daily doses of temozolomide will begin on Day of the first cycle and continue until the last dose of radiation therapy in cycle 1
Each participant will receive 7 weeks of radiation therapy Radiation therapy will start on Day 5 of the first cycle and will be administered monday through friday except on holidays
When radiation stops temozolomide and PTK will be given for a maximum of 6 post-radiation cycles of study treatment During these cycles PTK and temozolomide will be given for 5 consecutive days followed by 23 days of no drugs
Tests will be performed routinely throughout the study treatment and include chest x-rays blood tests physical exams urine tests and ECG
The following procedures will be performed at the end of the study or after the participants last dose of study medication tumor assessment by MRI routine blood draws neurologicalphysical exam and medical history review
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