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Active Not Recruiting
NCT01087554
Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer
Conditions: Advanced Cancer
Sex: All
Healthy volunteers: No
Phase: PHASE1
Enrollment: 249
Sponsor: M.D. Anderson Cancer Center
Location: University of Texas MD Anderson Cancer Center Houston Texas
Summary
The goal of this clinical research study is to find the highest tolerable dose of the combination vorinostat given in combination with either sirolimus, everolimus or temsirolimus that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.
The Study Drugs:
Vorinostat is designed to prevent or slow down the growth of cancer cells by blocking proteins.
Everolimus is designed to stop cells from dividing. This may stop or slow the growth or spread of cancer cells.
Temsirolimus is designed to block a protein called mTOR (a protein that is thought to cause cancer cells to grow) inside the cancer cell. This may interfere with the growth or spread of cancer cells or possibly kill them.
Sirolimus is designed to block a protein called mTOR inside the cancer cell. This may interfere with the growth or spread of cancer cells or possibly kill the cancer cells.
This is an investigational study. Sirolimus is FDA approved and commercially available as an anti-rejection drug for kidney transplant recipients. Everolimus is FDA-approved and commercially available for the treatment of pancreatic neuroendocrine tumor, subependymal giant cell astrocytoma, and renal cell carcinoma. Temsirolimus is FDA approved and commercially available for the treatment of renal cell carcinoma. Vorinostat is FDA approved and commercially available for the treatment of cutaneous T-cell lymphoma. The combination of these drugs is investigational.
Up to 249 patients will take part in this study. All will be enrolled at MD Anderson.
Eligibility Criteria
Inclusion Criteria:
1. Patients must have a histologically-confirmed metastatic or locally advanced cancer that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy that increases survival by at least three months does not exist
2. There is no limit on the number of prior treatment regimens
3. Patients must be off prior cytotoxic chemotherapy for at least three weeks. For biologic or targeted therapy, there should be five half lives or three weeks, whichever is shorter, between their last treatment and the first dose on this trial.
4. Patients may receive palliative radiation therapy before or during treatment on protocol, provided that there is measurable or evaluable disease out of the radiation field. Patients may receive palliative radiation therapy, if needed, 48 hours after last dose of investigational drug. In addition patients may be enrolled on trial seven days following palliative radiation. We will closely monitor for the appearance of radiation recall reactions. Hormonal therapy may continue in patients who have been on such treatment for three months or longer.
5. ECOG performance status 0-3
6. Patients must have adequate organ and marrow function as defined by: absolute neutrophil count \>/= 1000uL, platelets \>/= 50,000uL, bilirubin \
Source: ClinicalTrials.gov (NCT01087554). StuddyBuddy aggregates publicly available trial information.