This phase II trial studies the side effects and how well vorinostat works in treating patients with primary cutaneous T-cell lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
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.
Time frame: After at least 14 days. With Confirmation after additional 28 days.
Objective Response Rate of Extracutaneous Manifestations of CTCL (Lymph Node Enlargement, Sezary Cells in Peripheral Blood);
Assessed by changes in the sum of the products in the greatest diameters of enlarged lymph nodes by serial computed tomography (CT) or positron emission tomography (PET)/CT scans.
Time frame: Up to 30 days post-treatment
Occurrences of Dose Adjustment as Measured by Safety/Toxicity
Toxicities will be graded in severity according to the guidelines outlined in the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.
Time frame: Up to 30 days post-treatment
Number of Participants With Overall Response as Measured by Sezary Cell Count
Overall response defined by a clinically significant decrease in Sezary cell count (\>50% decrease from baseline).
Time frame: Baseline to 30 days post-treatment
Changes in the Physicians Serial Assessment of Erythroderma Score
Time frame: Baseline to 30 days post-treatment
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