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

Merck Sharp & Dohme LLC74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cutaneous T-cell Lymphoma Sezary Syndrome Mycosis Fungoides

Interventions

MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 MonthsDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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