Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050986
Status:
COMPLETED
Last Update Posted:
2020-09-22
First Post:
2002-12-31
Brief Title:
Phase III Evaluation of Temozolomide and ZARNESTRA R115777 for Recurrent and Progressive Glioblastoma Multiforme
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Evaluation Temozolomide and Farnesyl Transferase Inhibitor ZARNESTRA R115777 for the Treatment of Recurrent and Progressive Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2020-09
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 goal of this clinical research study is to find the highest safe dose of the new drug ZARNESTRA R115777 and temozolomide that can be given to patients with brain tumors glioblastoma multiforme GBM The second goal is to learn if these drugs given in combination can shrink or slow the growth of brain tumors The safety of this treatment will also be studied
Detailed Description:
Temozolomide works by killing cancer cells R115777 is a new drug that may slow down the growth of cancer cells Used in combination the two drugs may control the growth of brain tumors
Before treatment starts patients will have a complete exam including measurement of height and weight Blood tests less than 2 tablespoons of blood will be performed A MRI scan will be done Women who are able have children must have a negative blood pregnancy test
Temozolomide and R115777 will both be taken by mouth Participants in this study will take temozolomide once a day for 7 days every other week Days 1-7 and 15-21 This will be repeated every 28 days 1 course Patients must not eat for 1 hour before and after taking the drug drinking water is allowed All treatment may be given on an outpatient basis
During the alternate weeks Days 8-14 and 22-28 participants will take R115777 tablets by mouth in the morning and evening with food At the beginning of the study groups of 3 participants each will take increasing doses of both R115777 and temozolomide until the highest safe dose of each drug when given in combination is found Participants entering the study after the highest safe dose is found will receive that dosage
If tumors do not grow and serious side effects do not occur participants may keep on taking temozolomide and R115777 for up to 2 year If your physician thinks it is advisable treatment may continue with R115777 alone after that time In this case routine blood tests for counts liver and kidney function less than 2 tablespoons will be repeated every 4 weeks and MRI scans physical and neurological exams will be done every 8 weeks Participants may not receive any other treatment for cancer including surgery while taking part in this study
Participants will come to the clinic to have a complete physical and neurological exam and blood tests less than 2 tablespoons of blood before each course Blood tests will be repeated once a week for the first 2 courses of treatment and then on Days 14 and 28 of each later course A MRI scan will be done before the odd-numbered 3 5 7 etc courses of treatment or at any time clinically indicated
At the end of the study participants will have another complete physical exam Blood tests less than 2 tablespoons of blood will be performed A MRI scan will be done
This is an investigational study Temozolomide is approved by the FDA for the treatment of some brain tumors and is commercially available R115777 is approved for research use only in the treatment of brain tumors The use of these two drugs together is experimental
Before treatment starts patients will have a complete exam including measurement of height and weight Blood tests less than 2 tablespoons of blood will be performed A MRI scan will be done Women who are able have children must have a negative blood pregnancy test
Temozolomide and R115777 will both be taken by mouth Participants in this study will take temozolomide once a day for 7 days every other week Days 1-7 and 15-21 This will be repeated every 28 days 1 course Patients must not eat for 1 hour before and after taking the drug drinking water is allowed All treatment may be given on an outpatient basis
During the alternate weeks Days 8-14 and 22-28 participants will take R115777 tablets by mouth in the morning and evening with food At the beginning of the study groups of 3 participants each will take increasing doses of both R115777 and temozolomide until the highest safe dose of each drug when given in combination is found Participants entering the study after the highest safe dose is found will receive that dosage
If tumors do not grow and serious side effects do not occur participants may keep on taking temozolomide and R115777 for up to 2 year If your physician thinks it is advisable treatment may continue with R115777 alone after that time In this case routine blood tests for counts liver and kidney function less than 2 tablespoons will be repeated every 4 weeks and MRI scans physical and neurological exams will be done every 8 weeks Participants may not receive any other treatment for cancer including surgery while taking part in this study
Participants will come to the clinic to have a complete physical and neurological exam and blood tests less than 2 tablespoons of blood before each course Blood tests will be repeated once a week for the first 2 courses of treatment and then on Days 14 and 28 of each later course A MRI scan will be done before the odd-numbered 3 5 7 etc courses of treatment or at any time clinically indicated
At the end of the study participants will have another complete physical exam Blood tests less than 2 tablespoons of blood will be performed A MRI scan will be done
This is an investigational study Temozolomide is approved by the FDA for the treatment of some brain tumors and is commercially available R115777 is approved for research use only in the treatment of brain tumors The use of these two drugs together is experimental
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