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Complete title: A Phase II Prospective Non-Randomized Two-Arm Clinical Trial of Dose-Adjusted Schedule of Vorinostat in Patients With Primary Cutaneous T-Cell Lymphoma (CTCL) Who Did Not Receive Prior Systemic Therapy or Have Been Treated with Single Agent Targretin
|Research Study Number||6914|
|Principal Investigator||Andrei Shustov, MD|
Research Study Description
Vorinostat is currently approved by the FDA for patients with previously treated CTCL, and is prescribed at a specific dose level. For some patients the standard dose may be too low, while for other patients this dose is too high.
In this research study, some participants will start vorinostat at the standard dose and other participants will start vorinostat at a lower dose. The dose that each participant starts with will depend on his or her age. The dose level may be changed during the study based on how the participant is tolerating vorinostat.
Study participants will receive study treatment with vorinostat for about 8 to 9 months. Vorinostat is taken as a pill, by mouth. During the treatment period, participants will come to the Seattle Cancer Care Alliance (SCCA) outpatient clinic every 2 to 4 weeks.
After the end of study treatment, we would like participants to visit the clinic for follow-up every 2 months for 2 years. If participants are not able to come to the clinic after the end of treatment for follow-up visits, we will contact participants by phone.
Eligibility Criteria (must meet the following to participate in this study)
- Diagnosis of CTCL (stages IB, IIA, IIB, III, or IVA) including mycosis fungoides and/or Sezary syndrome
- No previous treatment, except for single agent Targretin
- Adequate organ function
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Previous systemic therapy, total skin electron beam (TSEB) therapy or extracorporeal photopheresis (ECP)
Other exclusion criteria may apply.
Hematologic Malignancies; Lymphoma; Non-Hodgkin's Lymphoma (NHL); Mycosis Fungoides/Sezary Syndrome
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