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

Phase 1/Phase 2
Open (Enrolling)
Advanced Cancers

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Trial Information

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

- 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

Up to 65 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients with pathologically confirmed advanced or metastatic cancer that is
refractory to standard therapy, relapsed after standard therapy, or has no standard
therapy that improves survival by at least 3 months (unless temsirolimus is indicated
as standard treatment for that disease).

2. Patients must have evaluable tumor(s) with documented PIK3 mutation and/or PTEN loss.

3. Patients must have creatinine /= 1,000/mL;
platelets >/= 50,000; bilirubin metastases: total bilirubin
4. Women of childbearing potential must have a negative baseline blood pregnancy test.
Women and men must agree to use adequate contraception (hormonal or barrier method of
birth control; abstinence) for the duration of study.

5. Patients must be off other anti-tumor agents for at least 5 half lives of the agent
or 4 wks from the last day of treatment, whichever is shorter. For cytotoxic
therapies, patients should be off treatment for 3 or more weeks.

6. Patients may not be receiving any other experimental agents that are not FDA

7. Ability to understand and willingness to sign a written consent document.

8. Treatment on this study may begin within 24 hours after Phase 0 dose of Temsirolimus.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Patients with creatinine clearance <10 mL/min

3. Patients with a known hypersensitivity to any of the components or metabolites of the
drug products.

4. Patients with major surgery within 30 days prior to entering study.

5. Patients on inhibitors or inducers of CYP3A4 metabolism will have the inhibitors or
inducers stopped unless clinically contraindicated. See section 6 (Concomitant
Medications) and Appendix E of the protocol for details.

Type of Study:


Study Design:

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

Outcome Measure:

Tumor Response

Outcome Time Frame:

Baseline to Disease Progression (restaged at 8 weeks and at 4 months)

Safety Issue:


Principal Investigator

Daniel Karp, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2009

Completion Date:

April 2016

Related Keywords:

  • Advanced Cancers
  • Advanced cancer
  • Advanced Cancer with genetic mutation
  • Phosphoinositides 3-kinase
  • PI3K
  • PIK3 mutations
  • Temsirolimus
  • CCI-779
  • Torisel
  • mTOR inhibitor
  • Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030