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

Compassionate Use of Vorinostat (MK0683) for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00419367
Enrollment
Unknown
Registered
2007-01-08
Start date
Unknown
Completion date
Unknown
Last updated
2022-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, T-Cell, Cutaneous

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.

Interventions

DRUGComparator: 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.

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026