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Clinical Trial NU 12H06

Title
A Randomized Phase I Dose-Escalation Trial of Carfilzomib with and without Romidepsin in Cutaneous T-Cell Lymphoma
Principal Investigator
Timothy Kuzel
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.NU 12H06
Purpose
The purpose of this study is to determine the highest tolerated dose of carfilzomib that can be given by itself or with romidepsin and to evaluate its effects, good and/or bad in treating cutaneous T-cell lymphoma (CTCL).
Overview
Romidepsin is approved by the Food and Drug Administration (FDA) for treatment of CTCL. Romidepsin is a histone deacetylase inhibitor. These types of drugs alter some proteins that are associated with cancerous cells. Carfilzomib is FDA approved for treatment of multiple myeloma but not for CTCL. Carfilzomib is a proteasome inhibitor. A proteasome is a protein found within cells that has the important role of identifying and marking damaged proteins that are needed to be destroyed by the cell for survival. This research is being done to see if carfilzomib will improve the treatment of CTCL.
Eligibility
Some of the eligibility criteria include:
  • Participants must be 18 years of age or older.
  • Participants must have cutaneous T-cell lymphoma.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Participants will be randomly assigned (by chance, like a coin toss) to receive either carfilzomib by itself or carfilzomib plus romidepsin. The dose of carfilzomib given is dependent upon the time of enrollment into the study. Both groups will receive 2 cycles of treatment. Each cycle consists of 28 days. After cycle 2, participants will be assessed for disease response and will either continue on in the study or be taken off the study treatment. Participants who continue in the study will be reassessed every 2 cycles there after. Treatment may continue for participants until the study doctor decides it is in their best interest to be removed from the study.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 02-Oct-14 11:29 AM

 

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