Vorinostat and Concurrent Whole Brain Radiotherapy for Brain Metastasis

Sponsor
National Taiwan University Hospital
Study ID
NCT01600742
Phase
PHASE2
Status
Terminated

Conditions

  • Brain Metastasis

Eligibility Criteria

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

Interventions

  • Vorinostat — DRUG
    Run-in phase: WBRT: 2.5 Gy per fraction per day, day 1 through day 5 every week for 15 days, to a total dose of 37.5Gy. Vorinostat: 400 mg/day during WBRT, day 1 through day 7 every week till one day after WBRT. Randomization phase: WBRT: 2.5 Gy per fraction per day, day 1 through day 5 every week for 15 days, to a total dose of 37.5Gy. Vorinostat or placebo: 400 or 300 mg/day during radiation therapy (based on the results of run-in phase), day 1 through day 7 every week till one day after WBRT.
  • Placebo — DRUG
    Randomization phase: WBRT: 2.5 Gy per fraction per day, day 1 through day 5 every week for 15 days, to a total dose of 37.5Gy. Vorinostat or placebo: 400 or 300 mg/day during radiation therapy (based on the results of run-in phase), day 1 through day 7 every week till one day after WBRT.

Study Details

Vorinostat is a potent and well tolerated HDAC inhibitor. It has been reported to enhance radiosensitivity of cancer cells. We hypothesize that the addition of vorinostat to WBRT may increase therapeutic efficacy for patients with brain metastases.

Key Dates

Start date
Aug 31, 2012
Status verified
Jan 2014
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

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

Arms

  • Active Comparator: WBRT, placebo
  • Experimental: WBRT and concurrent vorinostat

Primary Outcome Measure

To evaluate brain-specific progression free survival rate at 6 months [ Time Frame: 6 months ]

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