Vorinostat in Patients With Primary Cutaneous T-Cell Lymphoma

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• vorinostat — DRUG
  Given PO
• flow cytometry — OTHER
  correlative study
• laboratory biomarker analysis — OTHER
  correlative study

Study Details

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

Key Dates

Start date

Jul 31, 2009

Status verified

Sep 2018

Primary completion

Feb 28, 2013

Completion

Nov 30, 2013

Study Design

Enrollment

11 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort I (>=65 years old)
  200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.
• Experimental: Cohort II (<65 years old)
  400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.

Primary Outcome Measure

Objective Response [ Time Frame: After at least 14 days. With Confirmation after additional 28 days. ]

Locations (1)

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