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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT01187446
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Cutaneous Lymphoma
  • Cutaneous T-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Total skin electron beam therapy (TSEBT) — RADIATION
    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.
  • Vorinostat — DRUG
    Starting doses of is vorinostat 400 mg/day, continuing for 8 weeks.

Study Details

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.

Key Dates

Start date
Dec 31, 2010
Status verified
Oct 2017
Primary completion
Aug 31, 2013
Completion
Feb 28, 2014

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TSEBT & Vorinostat
    Total skin electron beam therapy (TSEBT) will be performed per institution guidelines. Vorinostat will be administered at a dose of 400 mg/day, starting one day prior to the initiation of TSEBT. During TSEBT, vorinostat should be taken in the morning and preferably prior to TSEBT.
  • Active Comparator: TSEBT only
    Total skin electron beam therapy (TSEBT) will be administered according to the Stanford 6-field technique or equivalent technique per institutional standards. Patients will receive a planned total skin dose of 12 grey (Gy) fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks. Supplements will routinely be applied to the perineum and soles as well as any other "shadowed" sites involved by disease, such as the inframammary regions (1-2 Gy fractions to a total dose of 12 Gy). Discrete tumors may receive additional "boost" treatment not to exceed 12 Gy.

Primary Outcome Measure

Complete Clinical Response (CCR) [ Time Frame: Week 8 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-
Yale University School of MedicineNew HavenConnecticut06520-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Stanford, CA

By research site
Stanford University School of Medicine· Stanford, CAYale University School of Medicine· New Haven, CTMD Anderson Cancer Center· Houston, TX

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