Compassionate Use of Vorinostat for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma (0683-042)

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00419367
First received: January 5, 2007
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

In an effort to allow patients continued access to vorinostat outside of the base study, patients that are actively receiving study medication will discontinue from this study and receive vorinostat via another method supported by the SPONSOR (e.g. Named Patient Program (NPP)). For those institutions that do not allow receipt of an investigational therapy outside of a clinical trial, patients that are actively receiving study medication and

continue to meet eligibility will transition to an extension phase of the study and the base study will be closed.

The extension phase will begin as soon as the protocol amendment is implemented.


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

Study Type: Expanded Access     What is Expanded Access?
Official Title: Compassionate Use of Vorinostat (MK0683) for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Intervention Details:
    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:

  • Advanced cutaneous T-cell lymphoma on or following two systemic therapies
  • Female participants must have a negative serum pregnancy test within 3 days of the first dose of vorinostat
  • Female participants must have finished menopause, or are surgically sterilized, or agree to use 2 adequate barrier methods of contraception
  • Male participants must agree to use 2 adequate barrier methods of contraception
  • To be treated on extension phase of study participant must have been treated on the base study for Protocol 042

Exclusion Criteria:

  • Currently receiving any potential histone deacetylase (HDAC) inhibitor (e.g. valproic acid)
  • Currently receiving any other systemic therapy for CTCL. Corticosteroids that are similar in strength to 20 mg of prednisone daily are permitted
  • Pregnant or lactating
  • Known allergy to any component of the study drug
  • Eligible for any other study of vorinostat in CTCL patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00419367     History of Changes
Other Study ID Numbers: 0683-042, MK0683-042, 2006_540
Study First Received: January 5, 2007
Last Updated: December 3, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014