A Phase II Prospective Non-Randomized Two-Arm Clinical Trial of Dose-Adjusted Schedule of Vorinostat in Patients With Primary Cutaneous T-Cell Lymphoma (CTCL) Who Did Not Receive Prior Systemic Therapy or Have Been Treated With Single Agent Targretin
PRIMARY OBJECTIVES:
I. To determine the objective response rate to treatment with dose-adjusted Vorinostat
schedule in subjects with cutaneous T-cell lymphoma (CTCL) who did not receive prior
systematic therapy or have been treated with single agent targretin (bexarotene).
SECONDARY OBJECTIVES:
I. To determine the safety and tolerability of dose-adjusted Vorinostat schedule when
administered to patients with primary cutaneous T-cell lymphoma who did not receive prior
systematic therapy or have been treated with single agent targretin.
II. To determine the time to objective response in subjects with CTCL treated with
dose-adjusted schedule of Vorinostat as primary therapy.
III To determine the duration of objective response in subjects with CTCL.
IV. To determine the time to loss of objective response.
V. To determine the objective response rate of extracutaneous manifestations of CTCL (lymph
node enlargement, Sezary cells in peripheral blood).
VI. To compare the efficacy, toxicity and tolerability of dose-adjusted schedule to
currently recommended flat dose of Vorinostat in subjects with CTCL.
OUTLINE: Patients are assigned to 1 of 2 treatment arms according to age (< 65 vs >= 65
years old).
COHORT I (>= 65 years old): Patients receive 200 mg vorinostat orally (PO) once daily (QD)
on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease
progression or unacceptable toxicity.
COHORT II (< 65 years old): Patients receive 400 mg vorinostat PO QD on days 1-28. Treatment
repeats every 28 days for 6 courses in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up for at least 30 days.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response
Defined as either no evidence of clinical disease or marked improvement (>= 50%) decrease in the modified Severity-Weighted Assessment Tool (mSWAT) skin assessment score compared to baseline.
After at least 28 days
No
Andrei Shustov
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
6914
NCT00958074
July 2009
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |