Oral SAHA (Suberoylanilide Hydroxamic Acid) in Advanced Cutaneous T-cell Lymphoma (0683-001)
Phase 2
Completed
- Conditions
- Cutaneous T-cell LymphomaSezary SyndromeMycosis Fungoides
- Registration Number
- NCT00091559
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Objective response rate in patients with progressive, persistent, or recurrent disease.
- Secondary Outcome Measures
Name Time Method Response duration, relief of pruritis, time to progression, time to objective response, safety & tolerability in this population.