Status:
TERMINATED
Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Advanced Cancers
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
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 and/or PTEN loss. The safety of this drug will also b...
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 thi...
Eligibility Criteria
Inclusion
- 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).
- Patients must have evaluable tumor(s) with documented PIK3 mutation and/or PTEN loss.
- Patients must have creatinine \</= 3 X upper limit of normal (ULN); absolute neutrophil count \>/= 1,000/mL; platelets \>/= 50,000; bilirubin \</= 3.0 gm/dL. Except for patients with liver metastases: total bilirubin \</= 5 ULN.
- 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.
- 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.
- Patients may not be receiving any other experimental agents that are not FDA approved.
- Ability to understand and willingness to sign a written consent document.
- Treatment on this study may begin within 24 hours after Phase 0 dose of Temsirolimus.
Exclusion
- Pregnant or lactating women.
- Patients with creatinine clearance \<10 mL/min
- Patients with a known hypersensitivity to any of the components or metabolites of the drug products.
- Patients with major surgery within 30 days prior to entering study.
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00877773
Start Date
April 1 2009
End Date
June 1 2014
Last Update
August 25 2016
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030