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Brain MetastasisPhase 2NCT01600742

Vorinostat and Concurrent Whole Brain Radiotherapy for Brain Metastasis

A Phase 2 study testing Vorinostat in people with Brain Metastasis, run by National Taiwan University Hospital at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Brain Metastasis
What is being tested?
Vorinostat
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4 participants
Where
1 siteTaiwan
Study dates
Aug 2012to Dec 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a histologic diagnosis of a malignancy (lung and breast cancers) and radiologic evidence of brain metastases that are not suitable for surgery or radiosurgery as judged on the basis of the lesion size, number, location and the patients' personal choices.
  • Patients with controlled systemic disease for >6 weeks (as judged on a case by case situation)
  • Age≧20 years
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≦3
  • Life expectancy of ≧6 months
  • No prior cranial radiotherapy
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  • Negative urine pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
  • Measurable lesions by gadolinium-enhanced MRI or contrast-enhanced CT scans. (≧10mm on T1-weighted gadolinium enhanced MRI or contrast-enhanced CT)
  • Patients must have adequate organ and marrow reserve measured within 7 days prior to randomization as defined below:
  • Hemoglobin >8.0 gm/dL;
  • Absolute neutrophil count > 1,000/mcL;
  • Platelets >100,000/mcL;
  • Total bilirubin ≤ 1.5 x UNL (upper normal limit);
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 x UNL; for patients with liver metastases, AST(SGOT)/ALT(SGPT) ≤ 5 x UNL is allowed;
  • Serum creatinine ≤ 1.5 x UNL;
  • PTT ≤ UNL;
  • INR ≤ 1.5;
  • Serum sodium, calcium, potassium, and magnesium levels are within normal limits.
  • Patients (or a surrogate) must be able to comply with study procedures and sign informed consent.

Who cannot join

  • Prior cranial RT.
  • Known hypersensitivity to any of the components of vorinostat.
  • Use of Valproic acid or other histone deacetylase inhibitor, ≤2 weeks prior to registration and during treatment.
  • Uncontrolled infection.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the prescribed regimens or limit compliance with study requirements.
  • History of myocardial infarction or unstable angina ≤6 months prior to registration or congestive heart failure (CHF) requiring use of ongoing maintenance therapy, or life-threatening ventricular arrhythmias.
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  • Inability to take oral medications.
  • Receiving any other investigational agent.
  • Congenital long QT syndrome.
  • Prolonged QTc interval (>450 msec)
  • Any of the following Category I drugs that are generally known to have a risk of causing Torsades de Pointes ≤7 days prior to registration: Quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycin, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine
  • Any of the following:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the duration of the study and for 3 weeks after treatment has ended.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: Vorinostat and Concomitant Whole Brain Radiation Therapy in Patients With Brain Metastases: A Randomized, Double-blind, Placebo-controlled, Phase II Study

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.

Read the detailed description

Whole brain radiotherapy (WBRT) is the treatment of choice for the majority of patients with brain metastases. Although WBRT yields high radiologic response rate (27~56%) and is effective in palliation of neurologic symptoms, the response duration is limited and neurologic progression remains the main cause of death in a significant number of patients.

Vorinostat is reasonably well tolerated and there is also compelling evidence that vorinostat may serve as a radiosensitizer. Preclinical studies of HDAC inhibition have also shown efficacy in neuron protection. These data suggest that the addition of vorinostat to the standard therapy of WBRT may potentially increase their therapeutic efficacy without increasing neurotoxicity, and support the rationale of this phase II trial of vorinostat with WBRT in patients with brain metastases.

Being tested
Vorinostat, Placebo
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VorinostatDrug

    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.

  • PlaceboDrug

    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 groups in NCT01600742
Study groupRoleWhat they receive
WBRT, placeboActive comparatorNot described
Receives: Drug: Placebo
WBRT and concurrent vorinostatExperimentalNot described
Receives: Drug: Vorinostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate brain-specific progression free survival rate at 6 months

    Measured: 6 months

Secondary outcomes (7)

  1. brain-specific PFS

    Measured: from randomization to progression of brain metastasis or death, assessed up to 36 months

  2. PFS

    Measured: from randomization to progression or death, assessed up to 36 months

  3. response rate

    Measured: 6 months

  4. time to neuro-cognitive progression

    Measured: 12 months

  5. time to neurologic progression

    Measured: 12 months

  6. HRQoL

    Measured: 12 months

  7. Overall survival

    Measured: from randomization to death, assessed up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Why it stopped: Sponsor stops to provide the study drug.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01600742
Sponsor's protocol ID
201110052MB
Status last verified
Jan 2014
First submitted
23 Apr 2012
Last updated
9 Jan 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vorinostat in people with Brain Metastasis, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor stops to provide the study drug.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate brain-specific progression free survival rate at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01600742.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.

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