Clinical Trial Detail

The purpose of this research study is to determine the safety and effects, good or bad, of the drug vorinostat in subjects with primary cutaneous T-cell lymphoma (CTCL) who have not received any previous treatment. The use of vorinostat in subjects who have not received any previous treatment for CTCL is experimental.

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.

- 18 years of age or older

- 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.

- Disease has progressed beyond the skin—CTCL involvement (M1) (CTCL stage IVB)

- Previous systemic therapy, total skin electron beam (TSEB) therapy or extracorporeal photopheresis (ECP)

Other exclusion criteria may apply.