Oral SAHA (Suberoylanilide Hydroxamic Acid) in Advanced Cutaneous T-cell Lymphoma (0683-001)

Sponsor

Merck Sharp & Dohme Corp. (Industry)

Overall Status

Completed

CT.gov ID

NCT00091559

Collaborator

(none)

Enrollment

13.2

Actual Duration (Months)

Study Details

Study Description

Brief Summary

A study for patients diagnosed with advanced cutaneous T-cell lymphoma (stage 1B or higher) who have progressive, persistent, or recurrent disease on or following 2 other therapies, one of which must have contained Targretin (bexarotene)or for patients who are not candidates or could not tolerate Targretin therapy.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous T-cell Lymphoma Sezary Syndrome Mycosis Fungoides	Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase IIb Multicenter Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Cutaneous T-cell Lymphoma

Actual Study Start Date :

Feb 3, 2005

Actual Primary Completion Date :

Nov 23, 2005

Actual Study Completion Date :

Mar 13, 2006

Outcome Measures

Primary Outcome Measures

Objective response rate in patients with progressive, persistent, or recurrent disease. []

Secondary Outcome Measures

Response duration, relief of pruritis, time to progression, time to objective response, safety & tolerability in this population. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with Cutaneous T-cell Lymphoma (Stage 1B or higher)
Age: over 18 years of age
Have the ability to swallow capsules.
You must be at least 3 weeks from any prior chemotherapy or anticancer therapy treatment and have recovered from any side effects of that treatment.
Patients also require adequate heart, liver, and kidney function.

Exclusion Criteria:

Pregnant and nursing women and those with known allergy to the study drug are excluded from this study.
Patients are excluded if they are currently receiving chemotherapy, radiation therapy, or other investigational anti-cancer therapy.
Patients diagnosed with HIV, active hepatitis or who require intravenous antibiotics or antifungal agents are not permitted.