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
About this trial
This is an expanded access trial for Lymphoma, T-Cell, Cutaneous
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00419367
First Posted
January 5, 2007
Last Updated
September 21, 2022
Sponsor
Merck Sharp & Dohme LLC
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
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Primary Completion Date
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Study Completion Date
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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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