Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01087554
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sirolimus — DRUG
    Escalation Phase: Sirolimus starting dose1 mg by mouth on Days 1 - 28. Expansion Phase starting dose: MTD from Escalation Phase.
  • Vorinostat — DRUG
    Arm A - Escalation Phase: Vorinostat starting dose 100 mg by mouth on Days 7 - 28 of Cycle 1; For all other cycles, dose of 100 mg Days 1-28. Expansion Phase starting dose: MTD from Escalation Phase. Arm B + Arm C - Escalation and Expansion Phase: Vorinostat dose 300 mg by mouth on Days 7 - 28. Rest of cycles: 300 mg by mouth on Days 1 - 28.
  • Everolimus — DRUG
    Escalation Phase: Everolimus starting dose 5 mg by mouth on Days 1 - 28. Expansion Phase: MTD from Escalation Phase.
  • Temsirolimus — DRUG
    Escalation Phase: Temsirolimus starting dose 12.5 mg by vein on Days 1, 8, 15, 22. Expansion Phase: MTD from Escalation Phase.

Study Details

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.

Key Dates

Start date
Mar 31, 2010
Status verified
Jan 2026
Primary completion
Aug 18, 2026
Completion
Aug 18, 2026

Study Design

Enrollment
249 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Vorinostat + Sirolimus
    Escalation Phase: Vorinostat starting dose 100 mg by mouth on Days 7 - 28 of Cycle 1; For all other cycles, dose of 100 mg Days 1-28. Expansion Phase starting dose: MTD from Escalation Phase. Escalation Phase: Sirolimus starting dose1 mg by mouth on Days 1 - 28. Expansion Phase starting dose: MTD from Escalation Phase.
  • Experimental: Arm B: Vorinostat + Everolimus
    Escalation and Expansion Phase: Vorinostat dose 300 mg by mouth on Days 7 - 28. Rest of cycles: 300 mg by mouth on Days 1 - 28. Escalation Phase: Everolimus starting dose 5 mg by mouth on Days 1 - 28. Expansion Phase: MTD from Escalation Phase.
  • Experimental: Arm C: Vorinostat + Temsirolimus
    Escalation and Expansion Phase: Vorinostat dose 300 mg by mouth on Days 7 - 28. Rest of cycles: 300 mg by mouth on Days 1 - 28. Escalation Phase: Temsirolimus starting dose 12.5 mg by vein on Days 1, 8, 15, 22. Expansion Phase: MTD from Escalation Phase.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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