Ignite Creation Date:
2024-05-05 @ 9:28 PM
Last Modification Date:
2024-10-26 @ 10:05 AM
Study NCT ID:
NCT00895960
Status:
TERMINATED
Last Update Posted:
2018-11-08
First Post:
2009-05-07
Brief Title:
Dasatinib Plus Radiation TherapyTemozolomide in Newly-Diagnosed Glioblastoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Trial of Dasatinib Sprycel With Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma
Status:
TERMINATED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor withdrew support Study did not progress to Phase II
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I
Primary Objectives
-To define the maximum tolerated dose MTD of dasatinib Sprycel with radiotherapy RT and 6 weeks of concomitant temozolomide TMZ administered at 75 mgm2day in patients with newly-diagnosed glioblastoma GBM
Secondary Objectives
To characterize the safety profile of dasatinib Sprycel in combination with radiotherapy RT and concomitant TMZ in patients with newly-diagnosed GBM
To characterize the safety profile of dasatinib Sprycel in combination with adjuvant TMZ in patients with glioblastoma after RT
STUDY DID NOT PROGRESS TO PHASE II PORTION
Phase II
Primary Objectives
-To determine the effectiveness of dasatinib Sprycel with radiotherapy RT and 6 weeks of concomitant temozolomide TMZ administered at 75 mgm2day followed by adjuvant temozolomide with concurrent dasatinib in patients with newly-diagnosed glioblastoma GBM as measured by overall survival
Secondary Objectives
To determine the efficacy of this treatment as measured by radiographic response RR progression-free survival PFS and time to progression TTP
To characterize the safety profile of dasatinib Sprycel in combination with RT and concomitant TMZ in patients with newly-diagnosed GBM
To characterize the safety profile of dasatinib Sprycel in combination with adjuvant TMZ in patients with GBM after RT
Exploratory Objectives
-To correlate tumor genotype tumor expression of dasatinib target proteins eg Src EphA2 c-kit and PDGFR and PTEN levels with response to therapy with dasatinib and temozolomide
Primary Objectives
-To define the maximum tolerated dose MTD of dasatinib Sprycel with radiotherapy RT and 6 weeks of concomitant temozolomide TMZ administered at 75 mgm2day in patients with newly-diagnosed glioblastoma GBM
Secondary Objectives
To characterize the safety profile of dasatinib Sprycel in combination with radiotherapy RT and concomitant TMZ in patients with newly-diagnosed GBM
To characterize the safety profile of dasatinib Sprycel in combination with adjuvant TMZ in patients with glioblastoma after RT
STUDY DID NOT PROGRESS TO PHASE II PORTION
Phase II
Primary Objectives
-To determine the effectiveness of dasatinib Sprycel with radiotherapy RT and 6 weeks of concomitant temozolomide TMZ administered at 75 mgm2day followed by adjuvant temozolomide with concurrent dasatinib in patients with newly-diagnosed glioblastoma GBM as measured by overall survival
Secondary Objectives
To determine the efficacy of this treatment as measured by radiographic response RR progression-free survival PFS and time to progression TTP
To characterize the safety profile of dasatinib Sprycel in combination with RT and concomitant TMZ in patients with newly-diagnosed GBM
To characterize the safety profile of dasatinib Sprycel in combination with adjuvant TMZ in patients with GBM after RT
Exploratory Objectives
-To correlate tumor genotype tumor expression of dasatinib target proteins eg Src EphA2 c-kit and PDGFR and PTEN levels with response to therapy with dasatinib and temozolomide
Detailed Description:
PHASE I
The Study Drugs
Dasatinib is designed to change the function of certain genes By changing the function of these genes it may prevent cancer from growing and spreading It is also designed to block or lower the activity of one or more tumor-causing proteins responsible for the uncontrolled growth of tumor cells which may result in shrinking or stopping tumor growth
Temozolomide is designed to kill cancer cells by damaging DNA the genetic material of cells The damaged DNA may cause tumor cell death
Study Groups
If you are found to be eligible to take part in this study you will be assigned to a dose level of dasatinib based on when you joined this study Up to 2 dose levels of dasatinib will be tested Three 3 participants will be enrolled at each dose level The first group of participants will receive the lowest dose level Each new group will receive a higher dose than the group before it if no intolerable side effects were seen This will continue until the highest tolerable dose of dasatinib given in combination with temozolomide is found
All the groups will take the same dose level of temozolomide for the entire study
The amount of study drugs you receive may change if you experience side effects If at any time you experience any intolerable side effects tell the study doctor right away
Study Drug Administration
During Radiation
As a part of standard of care you will receive radiation therapy Monday-Friday for a total of 30 radiation treatments about 6 weeks
Every day while you are receiving radiation you will take the temozolomide by mouth once a day for up to a maximum of 7 weeks
You should swallow temozolomide whole one right after the other without chewing them If you vomit while taking temozolomide you cannot take more capsules before the next scheduled dose They should be taken on an empty stomach at least 1 hour before and 2 hours after eating with 1 cup about 8 oz of water
Every day while you are receiving radiation you will take dasatinib by mouth 1 time a day for up to a maximum of 7 weeks You should take dasatinib without food 1 hour before or 2 hours after eating with at least 1 cup 8 oz of water
After Radiation
After the radiation therapy ends every day you will continually take dasatinib by mouth 1 time a day
You will not take temozolomide for about 4 weeks after the radiation therapy ends After 4 weeks you will begin taking temozolomide 1 time a day by mouth on Days 1-5 of each 28 day study cycle
Study Visits
Four 4 weeks after the end of radiation then every 4 weeks after that the following tests and procedures will be performed
You will have a physical exam including measurement of your vital signs
You will have a neurological exam
You will have a performance status evaluation
You will be asked about any drugs you may be taking and if you have experienced any side effects
Blood about 1 teaspoon will be drawn to check your bloods ability to clot normally
Every week for the first 6 weeks then every 4 weeks after that you will be asked if you have experienced any side effects
If you are taking an anti-seizure drug every 2 weeks for the first 6 weeks and then every 4 weeks after that blood about 1 teaspoon will be drawn to check the levels of anti-seizure drug in your blood
At Week 6 then before each cycle after radiation for the first 6 cycles you will have an ECG
Every week for the first 6 weeks then on Days 1 and 22 of every cycle after radiation blood about 3 teaspoons will be collected for routine tests
Four 4 weeks after the end of radiation then every 8 weeks after that you will have an MRI scan to check the status of the disease
Length of Study
You may continue taking temozolomide for up to 12 cycles You may continue taking dasatinib for as long as you are benefitting You will be taken off study early if the disease gets worse or you experience intolerable side effects
End-of-Study Visit
After you go off study you will have an end-of-study visit At this visit the following tests and procedures will be performed
Your complete medical history will be recorded
You will have a physical exam
You will have a performance status evaluation
You will be asked about any drugs you may be taking and if you have experienced any side effects
You will have a neurological exam
Blood about 3 12 teaspoons will be collected for routine tests and to check your bloods ability to clot normally
If you are taking an anti-seizure drug blood about 1 teaspoon will be drawn to check the level of anti-seizure drug in your blood
Long-Term Follow-up visit
After the end-of-study visit the study teamstaff will contact you by telephone every 3 months to check how you are doing Each phone call will take about 5 minutes
This is an investigational study Temozolomide is FDA approved and commercially available for the treatment of brain tumors Dasatinib is FDA approved and commercially available for the treatment of some types of leukemia but it is experimental for use in brain tumors In addition the combination of temozolomide and dasatinib is experimental for use in brain tumors At this time the combination is only being used in research
Up to 72 participants will take part in this study Up to 72 will be enrolled at M D Anderson
The Study Drugs
Dasatinib is designed to change the function of certain genes By changing the function of these genes it may prevent cancer from growing and spreading It is also designed to block or lower the activity of one or more tumor-causing proteins responsible for the uncontrolled growth of tumor cells which may result in shrinking or stopping tumor growth
Temozolomide is designed to kill cancer cells by damaging DNA the genetic material of cells The damaged DNA may cause tumor cell death
Study Groups
If you are found to be eligible to take part in this study you will be assigned to a dose level of dasatinib based on when you joined this study Up to 2 dose levels of dasatinib will be tested Three 3 participants will be enrolled at each dose level The first group of participants will receive the lowest dose level Each new group will receive a higher dose than the group before it if no intolerable side effects were seen This will continue until the highest tolerable dose of dasatinib given in combination with temozolomide is found
All the groups will take the same dose level of temozolomide for the entire study
The amount of study drugs you receive may change if you experience side effects If at any time you experience any intolerable side effects tell the study doctor right away
Study Drug Administration
During Radiation
As a part of standard of care you will receive radiation therapy Monday-Friday for a total of 30 radiation treatments about 6 weeks
Every day while you are receiving radiation you will take the temozolomide by mouth once a day for up to a maximum of 7 weeks
You should swallow temozolomide whole one right after the other without chewing them If you vomit while taking temozolomide you cannot take more capsules before the next scheduled dose They should be taken on an empty stomach at least 1 hour before and 2 hours after eating with 1 cup about 8 oz of water
Every day while you are receiving radiation you will take dasatinib by mouth 1 time a day for up to a maximum of 7 weeks You should take dasatinib without food 1 hour before or 2 hours after eating with at least 1 cup 8 oz of water
After Radiation
After the radiation therapy ends every day you will continually take dasatinib by mouth 1 time a day
You will not take temozolomide for about 4 weeks after the radiation therapy ends After 4 weeks you will begin taking temozolomide 1 time a day by mouth on Days 1-5 of each 28 day study cycle
Study Visits
Four 4 weeks after the end of radiation then every 4 weeks after that the following tests and procedures will be performed
You will have a physical exam including measurement of your vital signs
You will have a neurological exam
You will have a performance status evaluation
You will be asked about any drugs you may be taking and if you have experienced any side effects
Blood about 1 teaspoon will be drawn to check your bloods ability to clot normally
Every week for the first 6 weeks then every 4 weeks after that you will be asked if you have experienced any side effects
If you are taking an anti-seizure drug every 2 weeks for the first 6 weeks and then every 4 weeks after that blood about 1 teaspoon will be drawn to check the levels of anti-seizure drug in your blood
At Week 6 then before each cycle after radiation for the first 6 cycles you will have an ECG
Every week for the first 6 weeks then on Days 1 and 22 of every cycle after radiation blood about 3 teaspoons will be collected for routine tests
Four 4 weeks after the end of radiation then every 8 weeks after that you will have an MRI scan to check the status of the disease
Length of Study
You may continue taking temozolomide for up to 12 cycles You may continue taking dasatinib for as long as you are benefitting You will be taken off study early if the disease gets worse or you experience intolerable side effects
End-of-Study Visit
After you go off study you will have an end-of-study visit At this visit the following tests and procedures will be performed
Your complete medical history will be recorded
You will have a physical exam
You will have a performance status evaluation
You will be asked about any drugs you may be taking and if you have experienced any side effects
You will have a neurological exam
Blood about 3 12 teaspoons will be collected for routine tests and to check your bloods ability to clot normally
If you are taking an anti-seizure drug blood about 1 teaspoon will be drawn to check the level of anti-seizure drug in your blood
Long-Term Follow-up visit
After the end-of-study visit the study teamstaff will contact you by telephone every 3 months to check how you are doing Each phone call will take about 5 minutes
This is an investigational study Temozolomide is FDA approved and commercially available for the treatment of brain tumors Dasatinib is FDA approved and commercially available for the treatment of some types of leukemia but it is experimental for use in brain tumors In addition the combination of temozolomide and dasatinib is experimental for use in brain tumors At this time the combination is only being used in research
Up to 72 participants will take part in this study Up to 72 will be enrolled at M D Anderson
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