Brain CancerPhase 1NCT00946673
Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer
A Phase 1 study testing Vorinostat and Radiation Therapy in people with Brain Cancer and Neoplasm Metastasis, run by Stanford University at 2 sites in United States.
Trial summary
The purpose of this study is to determine the maximum tolerated dose (MTD) of vorinostat given concurrently with stereotactic radiosurgery (SRS) to treat non-small cell lung cancer (NSCLCA) brain metastases in patient with 1-4 lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer, Neoplasm Metastasis, Lung Cancer
- What is being tested?
- Vorinostat and Radiation Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Jul 2015
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients age 18 years and older with histologically proven non-small cell lung cancer and 1-4 brain metastases, each measuring less than 2 cm will be eligible. Prior surgery or radiation is allowed as long as the target metastatic lesion(s) has not been treated with previous radiation.
- Adequate organ function (section 3.1.10).
- ECOG performance status 0-2.
- Life expectancy of >=12 weeks.
- Systemic chemotherapy washout period >=7 days.
Who cannot join
- Patients who have previously been treated with whole brain irradiation, pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University School of Medicine
Stanford, California, 94305
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer
The purpose of this study is to determine the maximum tolerated dose (MTD) of vorinostat given concurrently with stereotactic radiosurgery (SRS) to treat non-small cell lung cancer (NSCLCA) brain metastases in patient with 1-4 lesions.
- Being tested
- Vorinostat, Radiation Therapy
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VorinostatDrug
Orally up to 400 mg
Radiation TherapyProcedure or surgery
Single fraction stereotactic radiotherapy - Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| vorinostat & stereotactic radiosurgery | Experimental | Not described Receives: Drug: Vorinostat; Procedure: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined.
Measured: 30 days following Stereotactic Radiosurgery
During the expanded phase I portion of the study, the safety of the Maximum tolerated dose dose will be confirmed.
Measured: 30 days following Stereotactic Radiosurgery
The radiologic response, defined as local control and distant intra-cranial control rates at 3-months following radiotherapy, will be determined.
Measured: 3 months following Stereotactic Radiosurgery
Secondary outcomes (2)
The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined.
Measured: 12 months
The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Principal investigator, Griffith R Harsh, Stanford University
- Investigators
- Griffith R. Harsh, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946673
- Sponsor's protocol ID
- LUN0036
- Status last verified
- Oct 2017
- First submitted
- 23 Jul 2009
- Last updated
- 6 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00946673
- Acronym / sponsor ID
- LUN0036
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- Jun 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the maximum tolerated dose (MTD) of vorinostat given concurrently with stereotactic radiosurgery (SRS) to treat non-small cell lung cancer (NSCLCA) brain metastases in patient with 1-4 lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vorinostat & stereotactic radiosurgery | Experimental | Drug: Vorinostat, Procedure: Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients age 18 years and older with histologically proven non-small cell lung cancer and 1-4 brain metastases, each measuring less than 2 cm will be eligible. Prior surgery or radiation is allowed as long as the target metastatic lesion(s) has not been treated with previous radiation.
- Adequate organ function (section 3.1.10).
- ECOG performance status 0-2.
- Life expectancy of >=12 weeks.
- Systemic chemotherapy washout period >=7 days.
Key exclusion criteria (1 listed)
- Patients who have previously been treated with whole brain irradiation, pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VorinostatOrally up to 400 mg | Drug | vorinostat & stereotactic radiosurgery |
| Radiation TherapySingle fraction stereotactic radiotherapy - Standard of Care | Procedure or surgery | vorinostat & stereotactic radiosurgery |
Primary outcome
The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined.
Time frame: 30 days following Stereotactic Radiosurgery
During the expanded phase I portion of the study, the safety of the Maximum tolerated dose dose will be confirmed.
Time frame: 30 days following Stereotactic Radiosurgery
The radiologic response, defined as local control and distant intra-cranial control rates at 3-months following radiotherapy, will be determined.
Time frame: 3 months following Stereotactic Radiosurgery
2 secondary outcomes
The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined.
Time frame: 12 months
The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Griffith R. Harsh principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vorinostat and Radiation Therapy in people with Brain Cancer and Neoplasm Metastasis, run by Stanford University at 2 sites in United States.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined. (time frame: 30 days following Stereotactic Radiosurgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2017.