MedTrace Logo

Low-dose (12 Gy) TSEBT+Vorinostat Versus Low-dose TSEBT Monotherapy in Mycosis Fungoides

NCT01187446 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-11-20

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine if vorinostat combined with low-dose total skin electron beam therapy (TSEBT) offers superior clinical benefit (efficacy \& safety) over low-dose TSEBT alone in participants with mycosis fungoides (MF)

Treatment in this study is TSEBT +/- vorinostat, with participants stratified by MF stage.

Conditions

  • Cutaneous Lymphoma
  • Cutaneous T-cell Lymphoma

Interventions

RADIATION

Total skin electron beam therapy (TSEBT)

TSEBT is administered as 12 Gy fractionated at 2 grey (Gy)/cycle (each cycle requiring 2 days of treatment); 4 days each week; for 3 weeks.

DRUG

Vorinostat

Starting doses of is vorinostat 400 mg/day, continuing for 8 weeks.

Sponsors & Collaborators

Principal Investigators

  • Youn H Kim · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-08-31
Completion
2014-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01187446 on ClinicalTrials.gov