Brain MetastasesPhase 2NCT00589212
GliaSite 1-3 Mets Study
A Phase 2 study testing GliaSite Radiation Therapy System in people with Brain Metastases, run by Hologic, Inc. at 1 site in United States.
Trial summary
This study has been designed to compile information on the efficacy of the GliaSite RTS combined with radiosurgery in the treatment of newly diagnosed metastatic brain tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- GliaSite Radiation Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Mar 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have 1-3 newly diagnosed supratentorial metastatic brain lesions with at least one being dominant and eligible for surgical resection as visualized on enhanced MRI scan
- Have histological evidence of metastatic carcinoma on intraoperative pathology (frozen section) or final pathology report
- Have a Karnofsky Performance Status (KPS) >=70
- Have systemic disease which is judged to be stable and has been staged within the last 6 weeks
- Have a life expectancy of >= 6 month, based upon extent of systemic disease
- Be at least 18 years of age Give informed consent (or have legal representative give informed consent)
Who cannot join
- Be receiving or have plans to receive conventional or investigational systemic agents for the metastatic brain tumor.
- Be receiving or have plans to receive external beam radiation therapy to the brain.
- Have received prior conventional or investigational systemic agents, including the use of Gliadel Wafers or Temodar, for the treatment of the brain metastasis.
- Be pregnant or breast-feeding.
- Have uncontrolled hypertension, unstable angina pectoris, evidence of uncontrolled cardiac dysrhythmia.
- Have other serious concurrent infection or other medical illness which would jeopardize the ability of the patient to safely undergo resection and brachytherapy.
- Have histology of lymphoma or small-cell lung cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist University Hospital
Memphis, Tennessee, 38104
About this study
Official title: A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases
This study has been designed to compile information on the efficacy of the GliaSite RTS combined with radiosurgery in the treatment of newly diagnosed metastatic brain tumors.
Read the detailed description
Data relevant to the evaluation the effectiveness of the GliaSite RTS for a resected dominant brain metastases will be collected. The GliaSite RTS is a radionuclide applicator and liquid radionuclide (Iotrex) designed to deliver intracavitary radiation therapy for resected brain tumors. In this case, it will irradiate the resected margins. Brain metastases not surgically removed will be then treated with radiosurgery
- Conditions
- Brain Metastases
- Being tested
- GliaSite Radiation Therapy System
- Keywords
- GliaSite, Brain metastases, 1-3 METS
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GliaSite Radiation Therapy SystemDevice
GliaSite RTS is designed to deliver intracavitary radiation therapy for brain tumors. Following surgical resection, the balloon catheter is inflated to fill the cavity and Iotrex radiotherapy solution infused. It is a single applicator system that provides a uniform and conformal dose to the resection cavity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients with 1-3 brain metastases Receives: Device: GliaSite Radiation Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is to evaluate the 6 month and 1 year local control rate for 1-3 brain metastases treated with intracavitary radiation therapy.
Measured: Data collected at the time of implant, within 72 hours of implant, pre-brachytherapy, brachytherapy, radiosurgery, 1 and 3 months post brachytherapy and every 3 months thereafter
Secondary outcomes (1)
Overall survival, distant brain recurrence, toxicity and quality of life.
Measured: Survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study startOct 2003
- Primary completionMar 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Methodist Healthcare - Memphis
- Investigators
- Allen K Sills, Jr., MD, Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589212
- Sponsor's protocol ID
- GS-700
- Status last verified
- Jun 2008
- First submitted
- 24 Dec 2007
- Last updated
- 11 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases
- ClinicalTrials.gov ID
- NCT00589212
- Acronym / sponsor ID
- GS-700
- Conditions
- Brain Metastases
- Keywords
- GliaSite, Brain metastases, 1-3 METS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Methodist Healthcare - Memphis
- Study start
- Oct 2003
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 9 Jan 2008 (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.
This study has been designed to compile information on the efficacy of the GliaSite RTS combined with radiosurgery in the treatment of newly diagnosed metastatic brain tumors.
Detailed description
Data relevant to the evaluation the effectiveness of the GliaSite RTS for a resected dominant brain metastases will be collected. The GliaSite RTS is a radionuclide applicator and liquid radionuclide (Iotrex) designed to deliver intracavitary radiation therapy for resected brain tumors. In this case, it will irradiate the resected margins. Brain metastases not surgically removed will be then treated with radiosurgery
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: GliaSite Radiation Therapy SystemPatients with 1-3 brain metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have 1-3 newly diagnosed supratentorial metastatic brain lesions with at least one being dominant and eligible for surgical resection as visualized on enhanced MRI scan
- Have histological evidence of metastatic carcinoma on intraoperative pathology (frozen section) or final pathology report
- Have a Karnofsky Performance Status (KPS) >=70
- Have systemic disease which is judged to be stable and has been staged within the last 6 weeks
- Have a life expectancy of >= 6 month, based upon extent of systemic disease
Key exclusion criteria (7 listed)
- Be receiving or have plans to receive conventional or investigational systemic agents for the metastatic brain tumor.
- Be receiving or have plans to receive external beam radiation therapy to the brain.
- Have received prior conventional or investigational systemic agents, including the use of Gliadel Wafers or Temodar, for the treatment of the brain metastasis.
- Be pregnant or breast-feeding.
- Have uncontrolled hypertension, unstable angina pectoris, evidence of uncontrolled cardiac dysrhythmia.
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 |
|---|---|---|
| GliaSite Radiation Therapy SystemGliaSite RTS is designed to deliver intracavitary radiation therapy for brain tumors. Following surgical resection, the balloon catheter is inflated to fill the cavity and Iotrex radiotherapy solution infused. It is a single applicator system that provides a uniform and conformal dose to the resection cavity. | Device | 1 |
Primary outcome
The primary endpoint of this study is to evaluate the 6 month and 1 year local control rate for 1-3 brain metastases treated with intracavitary radiation therapy.
Time frame: Data collected at the time of implant, within 72 hours of implant, pre-brachytherapy, brachytherapy, radiosurgery, 1 and 3 months post brachytherapy and every 3 months thereafter
1 secondary outcome
Overall survival, distant brain recurrence, toxicity and quality of life.
Time frame: Survival
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 11 Jun 2008.
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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.
Allen K Sills, Jr., MD principal investigator
University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GliaSite Radiation Therapy System in people with Brain Metastases, run by Hologic, Inc. at 1 site 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 6 inclusion and 7 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 11 Jun 2008. 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 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 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 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 primary endpoint of this study is to evaluate the 6 month and 1 year local control rate for 1-3 brain metastases treated with intracavitary radiation therapy. (time frame: Data collected at the time of implant, within 72 hours of implant, pre-brachytherapy, brachytherapy, radiosurgery, 1 and 3 months post brachytherapy and every 3 months thereafter). 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 11 Jun 2008.