Spots Global Cancer Trial Database for Vorinostat in Patients With Primary Cutaneous T-Cell Lymphoma

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Trial Identification

Brief Title: Vorinostat in Patients With Primary Cutaneous T-Cell Lymphoma

Official Title: A Phase II Prospective Non-Randomized Clinical Trial of Dose-Adjusted Schedule of Vorinostat in Patients With Primary Cutaneous T-Cell Lymphoma Who Did Not Receive Prior Systemic Therapy or Have Been Treated With Single Agent Targretin

Study ID: NCT00958074

Conditions

Cutaneous T-cell Lymphoma Stage I

Cutaneous T-cell Lymphoma Stage II

Cutaneous T-cell Lymphoma Stage III

Cutaneous T-cell Lymphoma Stage IV

Interventions

vorinostat

flow cytometry

laboratory biomarker analysis

Study Description

Brief Summary: 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

Detailed Description: 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.