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

Primary Purpose

Lymphoma, T-Cell, Cutaneous

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Comparator: vorinostat
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Lymphoma, T-Cell, Cutaneous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2007
    Last Updated
    September 21, 2022
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00419367
    Brief Title
    Compassionate Use of Vorinostat for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma (0683-042)
    Official Title
    Compassionate Use of Vorinostat (MK0683) for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma, T-Cell, Cutaneous

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: vorinostat
    Intervention Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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