An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cutaneous T-Cell Lymphoma
Intervention: Suberoylanilide Hydroxamic Acid (SAHA) (Drug); bexarotene (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
This is an investigational study that increases the dosage to determine the
safety/tolerability, and efficacy of a histone deacetylase inhibitor in combination with
Targretin in patients with cutaneous T-cell lymphoma in patients who have failed at least one
prior systemic therapy.
Clinical Details
Official title: A Phase I Clinical Trial of Oral Suberoylanilide Hydroxamic Acid in Combination With Bexarotene in Patients With Advanced Cutaneous T-Cell Lymphoma.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Maximum tolerated dose (MTD)
Secondary outcome: Safety and tolerability, response rate, time to response, response duration
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Women or men greater than or equal to 18 years of age
- Advanced cutaneous T-cell lymphoma, stage IB or higher including Sezary Syndrome with
progressive, persistent, or recurrent disease
- Failure of at least one systemic therapy, not including Targretin
- Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2 (measurement
to determine your ability to perform daily activities)
Exclusion Criteria:
- Patient has had investigational treatment in the preceding 30 days
- Active hepatitis B or C, history of HIV
- Prior treatment with any HDAC inhibitor
- Patients must be disease free from prior malignancies for greater than 5 years,
except for curatively treated basal cell or squamous cell carcinoma of the skin or
carcinoma in-situ of the cervix
Locations and Contacts
Merck Sharp & Dohme - Chibret, A.G., Glattbrugg 8152, Switzerland
Merck Sharp & Dohme Ltd., Hoddesdon, Hertfordshire EN11 9BU, United Kingdom
Additional Information
Starting date: September 2005
Last updated: February 22, 2008
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