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About
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 and/or PTEN loss. The safety of this drug will also be tested.
Full 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:
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:
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.
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44 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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