An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED)

• Status: Terminated
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an investigational study that increases the dosage to determine the safety/tolerability, and efficacy of a histone deacetylase inhibitor in combination with Targretin in patients with cutaneous T-cell lymphoma in patients who have failed at least one prior systemic therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Bexarotene; Histone Deacetylase Inhibitors; Vorinostat

Criteria

Inclusion Criteria:

• Women or men greater than or equal to 18 years of age

• Advanced cutaneous T-cell lymphoma, stage IB or higher including Sezary Syndrome with progressive, persistent, or recurrent disease

• Failure of at least one systemic therapy, not including Bexarotene (Targretin)

• Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2 (measurement to determine your ability to perform daily activities)

Exclusion Criteria:

• Patient has had investigational treatment in the preceding 30 days

• Active hepatitis B or C, history of HIV

• Prior treatment with any HDAC inhibitor

• Patients must be disease free from prior malignancies for greater than 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix