Oral SAHA (Suberoylanilide Hydroxamic Acid) in Advanced Cutaneous T-Cell Lymphoma - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00091559

Purpose

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	Intervention	Phase
Cutaneous T-Cell Lymphoma Sezary Syndrome Mycosis Fungoides	Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months	Phase II

MedlinePlus related topics: Fungal Infections Lymphoma

Drug Information available for: Suberoylanilide hydroxamic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase IIb Multicenter Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Cutaneous T-Cell Lymphoma

Further study details as provided by Merck:

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.

Estimated Enrollment:	70
Study Start Date:	February 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091559

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Unaffiliated

More Information

Publications:

Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M. Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol. 2007 Jul 20;25(21):3109-15. Epub 2007 Jun 18.

Study ID Numbers:	2004_015
Study First Received:	September 10, 2004
Last Updated:	October 8, 2007
ClinicalTrials.gov Identifier:	NCT00091559 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

CTCL

Study placed in the following topic categories:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Immunoproliferative Disorders
Vorinostat
Sezary Syndrome
Mycosis Fungoides
Mycoses
Lymphatic Diseases
Analgesics, Non-Narcotic
Cutaneous T-cell Lymphoma

Lymphoma, T-Cell
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Sezary Syndrome
Mycosis Fungoides
Pathologic Processes
Sensory System Agents
Lymphoma, T-Cell
Syndrome
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Lymphoma

Immunoproliferative Disorders
Neoplasms by Histologic Type
Disease
Immune System Diseases
Vorinostat
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 06, 2009