Clinical Trial: Combination of Vorinostat and Bortezomib in Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase II Study To Determine The Safety and Efficacy Of The Combination of Vorinostat and Bortezomib In Patients With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
Brief Summary:
Primary Objectives:
- To evaluate the response rate for patients with T-cell Non-Hodgkin's Lymphoma (NHL)receiving the combination of vorinostat and bortezomib
- To evaluate the safety and tolerability of the combination of vorinostat and bortezomib in patients with relapsed or refractory T-cell NHL.
Secondary Objectives:
- To assess overall survival and time to treatment failure in patients with T-cell NHL treated with the combination of vorinostat and bortezomib.
- Correlative studies will be done to assess the role of vorinostat mediated apoptosis along with bortezomib synergy. Changes in marker expression from baseline to post treatment will be correlated with patient clinical response.
Detailed Summary:
The Study Drugs:
Vorinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die.
Bortezomib is designed to block a protein that plays a role in cell function and growth. This may cause cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, on Days 1-14 of each 21-day study cycle, you will take vorinostat. Vorinostat capsules are taken by mouth, 2 times a day (1 time in the morning and 1 time in the evening). The capsules must be taken with food (within 30 minutes after a meal).
On Days 1, 4, 8, and 11 of all cycles you will receive bortezomib through a needle in your vein. This will take less than 1 minute.
If you begin to experience severe or intolerable side effects, the study drug schedule may be stopped for up to 2 weeks. If the side effects improve, you may be able to begin to receive the study drugs again, with a lower dose of bortezomib. The vorinostat dose will not be changed. If you continue to have severe or intolerable side effects with the lower dose of bortezomib, you will be taken off study.
Study Visits:
On Day 1 of all cycles, the following tests and procedures will be performed:
- You will receive the vorinostat capsules (a 14-day supply for each study cycle) and instructions on how to take the drug. You will be instructed to return
Sponsor: M.D. Anderson Cancer Center
Current Primary Outcome: Number of Patients With Response [ Time Frame: Every two 21-day cycles ]
Computed tomography scans and/or Positron emission tomography (PET) scans obtained every two cycles to evaluate response using International Workshop Criteria of Complete Response, Partial Response, Progressive Disease, or Stable Disease.
Original Primary Outcome: To test how well the drugs vorinostat and Velcade® (bortezomib) work in combination to treat patients with T-cell NHL that has come back or is resistant to treatment. [ Time Frame: 4 Years ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: M.D. Anderson Cancer Center
Dates:
Date Received: December 16, 2008
Date Started: January 2009
Date Completion:
Last Updated: August 1, 2012
Last Verified: August 2012
