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

Phase 1

Terminated

• Conditions: Lymphoma
• Interventions: Drug: vorinostat

• Registration Number: NCT00127101
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-08-02
• Study First Submitted QC: 2005-08-04
• Study First Posted: 2005-08-05
• Study Start: 2005-09
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-07-06
• Results First Submitted QC: 2009-07-06
• Results First Posted: 2009-08-14
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	vorinostat	Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
Cohort 2	vorinostat	Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
Cohort 2a	vorinostat	Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter\[2\] daily x 7 days per week
Cohort 2b	vorinostat	Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter\[2\] daily x 7 days per week
Cohort 6	vorinostat	Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
Cohort 7	vorinostat	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)

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities	Day 1 to day 28	Number of patients with Dose Limiting Toxicities (DLT). A DLT is an adverse event that determined the treatment dose level was not tolerable for that patient in Cycle 1.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Responded to Treatment	Every 28 days for up to 6 Months of Treatment	Disease burden as assessed by the pre-specified Severity Weighted Assessment Tool (SWAT) measurement. A Response is defined as equal to or greater than 50% improvement in SWAT score.; SWAT Score is determined by the Lesions classified as patch, plaque, or tumor. The sum of percent of total body surface area (%TBSA) by lesion type is derived and multiplied by a factor of 1 (for patch), 2 (for plaque), or 4 (for tumor). The skin score total is derived by summing the skin score subtotals for patches, plaques and tumors. The skin score total is dimensionless and can range from 0 to 400