Clinical Trial NU 12H06
- A Randomized Phase I Dose-Escalation Trial of Carfilzomib with and without Romidepsin in Cutaneous T-Cell Lymphoma
- Principal Investigator
- Timothy Kuzel
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.NU 12H06
- 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).
- 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.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Participants must have cutaneous T-cell lymphoma.
- 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.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
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- A Phase 1 Open-label Study of Safety and Tolerability of MEDI4736 in Subjects with Metastatic or Unresectable Melanoma in Combination with Dabrafenib and Trametinib or with Trametinib Alone
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- A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination with High Dose Interferon-a in Advanced Melanoma
- A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma
- A Randomized Phase II Study of Sequential Biotherapy with Aflibercept and High Dose IL-2 versus High Dose IL-2 alone in Patients with Inoperable Stage III or Stage IV Melanoma: Efficacy and Biomarker Study
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last updated: 22-May-15 09:42 PM
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