Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients

Advanced Cancers Clinical Trial

Official title: Histology-Independent Study of the mTOR Inhibitor, Temsirolimus, in Patients With Advanced Cancer

Status Terminated

Clinical Trial 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 and/or PTEN loss. The safety of this drug will also be tested.

Clinical Trial 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, 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancers
• Neoplasms

• NCT number: NCT00877773
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 2009
• Completion date: June 2014