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

NCT00419367 | Unknown

• 4 other identifiers: 0683-042MK0683-0422006_5402006-003879-12
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

Comparator: vorinostat DRUG

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2007
• First Posted: January 8, 2007
• Last Updated: September 22, 2022

Record last verified: 2022-09