Compassionate Use of Vorinostat for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00419367

Purpose

This study will provide vorinostat to advanced CTCL patients who have no other treatment options for their disease. Safety and efficacy will be evaluated.

Condition	Intervention	Phase
Lymphoma, T-Cell, Cutaneous	Drug: Comparator: vorinostat	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Compassionate Use of Vorinostat (MK0683) for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Suberoylanilide hydroxamic acid

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

To provide drug on a compassionate use basis for the treatment of skin lesions in patients with CTCL who have been previously treated with at least two systemic medications. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety and efficacy of vorinostat in patients with CTCL. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	65
Study Start Date:	April 2007
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Single Arm	Drug: Comparator: vorinostat Each patient will receive open-label vorinostat 400 mg q.d. capsules. Treatment will continue until disease progression, intolerable toxicity, withdrawal of consent, or physician determines it is in best interest of patient to withdrawal.

Eligibility

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

Criteria

Inclusion Criteria:

Patient has advanced cutaneous T-cell lymphoma on or following two systemic therapies
Patient is greater than or equal to 18 years of age
Female patients must have a negative serum pregnancy test within 3 days of the first dose of vorinostat
Female patients must have finished menopause, or are surgically sterilized, or agree to use 2 adequate barrier methods of contraception
Male patients must agree to use 2 adequate barrier methods of contraception

Exclusion Criteria:

Patient is currently receiving any potential histone deacetylase (HDAC) inhibitor (e.g. valproic acid)
Patient is currently receiving any other systemic therapy for CTCL. Corticosteroids that are similar in strength to 20 mg of prednisone daily are permitted
Patient is pregnant or lactating
Patient has a known allergy to any component of the study drug
Patient is eligible for any other study of vorinostat in CTCL patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419367

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_540, MK0683-042
Study First Received:	January 5, 2007
Last Updated:	October 26, 2009
ClinicalTrials.gov Identifier:	NCT00419367 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anticarcinogenic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Sensory System Agents
Lymphoma, T-Cell
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Lymphoma
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases

Vorinostat
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Antirheumatic Agents
Central Nervous System Agents
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on February 08, 2010