Status:
COMPLETED
Temsirolimus In Phase 0
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The goal of this clinical research trial is to study the effects of the FDA-approved drug, temsirolimus, using a new type of clinical study design called a "Phase 0." This type of study may be able to...
Detailed Description
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 st...
Eligibility Criteria
Inclusion
- Patients with advanced or metastatic cancer, preferably with tumor easily accessible for biopsy.
- Patients should be at least four weeks or 5 half lives from the last day of chemotherapy, antibody or other biological therapy, whichever is shorter.
- Patients should preferably be undergoing screening for 2007-0668, 2008-0384, 2008-0425, and 2008-0827 (currently active Phase I trials involving temsirolimus). However, patients may also be allowed on protocol if they are undergoing screening for any study.
Exclusion
- Pregnant or lactating women.
- Patients with a known hypersensitivity to any of the components or metabolites of the drug products.
- Patients with a known bleeding diathesis which would prevent safely obtaining a biopsy if a biopsy is indicated.
- Patients who are less than 18 years of age.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01417065
Start Date
August 1 2010
Last Update
June 23 2014
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030