Cutaneous T-cell Lymphoma Stage I Clinical Trial
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
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03380026 -
Mechlorethamine Induced Contact Dermatitis Avoidance Study
|
Phase 2 |