Temsirolimus In Phase 0

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 predict if a drug can affect cancer and may be able to prevent potentially useful study drugs from being discarded before they are fully tested.

The purpose of the study is not to treat the cancer, but to help improve general cancer treatment knowledge.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

1. Patients with advanced or metastatic cancer, preferably with tumor easily accessible for biopsy.

2. 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.

3. 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 Criteria:

1. Pregnant or lactating women.

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

3. Patients with a known bleeding diathesis which would prevent safely obtaining a biopsy if a biopsy is indicated.

4. Patients who are less than 18 years of age.