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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Lymphoma

Treatments: Drug: Comparator: bexarotene; Drug: vorinostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT00127101

0683-016

MK0683-016

2005_019

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

23 participants in 6 patient groups

Cohort 1

Experimental group

Description:

Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week

Treatment:

Drug: vorinostat

Drug: Comparator: bexarotene

Cohort 2

Experimental group

Description:

Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week

Treatment:

Drug: vorinostat

Drug: Comparator: bexarotene

Cohort 2a

Experimental group

Description:

Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter\[2\] daily x 7 days per week

Treatment:

Drug: vorinostat

Drug: Comparator: bexarotene

Cohort 2b

Experimental group

Description:

Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter\[2\] daily x 7 days per week

Treatment:

Drug: vorinostat

Drug: Comparator: bexarotene

Cohort 6

Experimental group

Description:

Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week

Treatment:

Drug: vorinostat

Drug: Comparator: bexarotene

Cohort 7

Experimental group

Description:

Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week \[150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)

Treatment:

Drug: vorinostat

Drug: Comparator: bexarotene