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

Lymphoma, T-Cell, Cutaneous Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00419367
• Other study ID #: 0683-042
• Secondary ID: MK0683-0422006_5
• Status: No longer available

Study information

• Verified date: September 2022
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC