Histology-Independent Study of the mTOR Inhibitor, Temsirolimus, in Patients With Advanced Cancer
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, and/or PET/CT 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor Response
Baseline to Disease Progression (restaged at 8 weeks and at 4 months)
No
Daniel Karp, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2008-0827
NCT00877773
April 2009
April 2016
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |