Ignite Creation Date:
2024-05-05 @ 9:23 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00877773
Status:
TERMINATED
Last Update Posted:
2016-08-25
First Post:
2009-04-07
Brief Title:
Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin PI3K-mTOR in Advanced Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Histology-Independent Study of the mTOR Inhibitor Temsirolimus in Patients With Advanced Cancer
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Accrual
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 learn if temsirolimus can help to control advanced cancer in patients who also have a PI3K mutation andor PTEN loss The safety of this drug will also be tested
Detailed Description:
The Study Drug
Temsirolimus is designed to block the growth of cancer cells which may cause the cancer cells to die
Study Drug Administration
If you are found to be eligible to take part in this study you will receive temsirolimus through a needle in your vein on Days 1 8 15 and 22 of each 4-week study cycle On Day 1 of Cycle 1 the study drug will be given over 60 minutes If you tolerate the study drug well on Day 1 of Cycle 1 it will be given over 30 minutes at all other scheduled administration dates as long as you still tolerate it well If the dose is not well tolerated the dose will be reduced for future study visits
You will receive Benadryl diphenhydramine or a similar drug by vein to help prevent side effects about 30 minutes before you receive the study drug
Study Visits
One 1 time each week on each day that the study drug is being given the following tests and procedures will be performed
Your weight and vital signs will be measured
You will be asked about any drugs you may be taking and about any side effects you may be having
Blood about 2 teaspoons each time will be drawn for pharmacodynamic PD testing PD testing measures how the level of study drug in your body may affect the disease This blood will be drawn at the following times
At 8 hours - 3 hours after the dose At 24 hours - 3 hours after the dose At 72 hours - 24 hours after the dose
Every 2 weeks blood about 2 teaspoons will be drawn for routine tests
Every 4 weeks you will have a physical exam women who are able to become pregnant will also have a blood about 1 teaspoon pregnancy test
Every 8 weeks you will have a CT scan MRI scan andor PETCT scan to check the status of the disease
Length of Study
You will be on study for as long as you are benefiting or the disease is stable You will be taken off study if the disease gets worse you have intolerable side effects or the study doctor thinks it is in your best interest
End-of-Study Visit
After you have finished taking the study drug the following tests and procedures will be performed
You will have a physical exam including measurement of your weight and vital signs
You will be asked about any drugs you may be taking and about any side effects you may be having
This is an investigational study Temsirolimus is FDA-approved and commercially available for the treatment of advanced renal cancer Its use in other types of cancer is investigational
Up to 65 patients will take part in this study All will be enrolled at MD Anderson
Temsirolimus is designed to block the growth of cancer cells which may cause the cancer cells to die
Study Drug Administration
If you are found to be eligible to take part in this study you will receive temsirolimus through a needle in your vein on Days 1 8 15 and 22 of each 4-week study cycle On Day 1 of Cycle 1 the study drug will be given over 60 minutes If you tolerate the study drug well on Day 1 of Cycle 1 it will be given over 30 minutes at all other scheduled administration dates as long as you still tolerate it well If the dose is not well tolerated the dose will be reduced for future study visits
You will receive Benadryl diphenhydramine or a similar drug by vein to help prevent side effects about 30 minutes before you receive the study drug
Study Visits
One 1 time each week on each day that the study drug is being given the following tests and procedures will be performed
Your weight and vital signs will be measured
You will be asked about any drugs you may be taking and about any side effects you may be having
Blood about 2 teaspoons each time will be drawn for pharmacodynamic PD testing PD testing measures how the level of study drug in your body may affect the disease This blood will be drawn at the following times
At 8 hours - 3 hours after the dose At 24 hours - 3 hours after the dose At 72 hours - 24 hours after the dose
Every 2 weeks blood about 2 teaspoons will be drawn for routine tests
Every 4 weeks you will have a physical exam women who are able to become pregnant will also have a blood about 1 teaspoon pregnancy test
Every 8 weeks you will have a CT scan MRI scan andor PETCT scan to check the status of the disease
Length of Study
You will be on study for as long as you are benefiting or the disease is stable You will be taken off study if the disease gets worse you have intolerable side effects or the study doctor thinks it is in your best interest
End-of-Study Visit
After you have finished taking the study drug the following tests and procedures will be performed
You will have a physical exam including measurement of your weight and vital signs
You will be asked about any drugs you may be taking and about any side effects you may be having
This is an investigational study Temsirolimus is FDA-approved and commercially available for the treatment of advanced renal cancer Its use in other types of cancer is investigational
Up to 65 patients will take part in this study All will be enrolled at MD 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01265 | REGISTRY | NCI CTRP | None |