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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Cutaneous T-cell Lymphoma

Mycosis Fungoides

Sezary Syndrome

Treatments

Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months

Study type

Interventional

Funder types

Industry

Identifiers

NCT00091559

0683-001

2004_015

Details and patient eligibility

About

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.

Enrollment

74 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.