Brain TumorPhase 4NCT00415467
Treatment of Resectable Malignant Brain Tumors
A Phase 4 study testing GliaSite Radiation Therapy System in people with Brain Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goals of this study are to evaluate each of the following items: 1. Time to recurrence in patients receiving brachytherapy with the GliaSite RTS 2. Overall survival (OS) in patients with malignant brain tumors who are undergoing surgical resection and brachytherapy treatment with the GliaSite® Radiation Therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- 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
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jul 2008
- Phase
- Phase 4
- 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
- Patient must have histologically proven malignant brain tumor
- Patient must be a candidate for surgical resection of the tumor mass.
- Patient must not be pregnant or breast-feeding. All patients with the potential for pregnancy should be counseled and requested to follow acceptable birth control methods to avoid conception.
- Patient must sign informed consent form
Who cannot join
- 1. Serious concurrent infection or medical illness which could jeopardize the ability of the patient to receive the GliaSite catheter with reasonable safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase IV GliaSite® Radiation Therapy System Registry Protocol for the Treatment of Resectable Malignant Brain Tumors
The goals of this study are to evaluate each of the following items:
- Time to recurrence in patients receiving brachytherapy with the GliaSite RTS
- Overall survival (OS) in patients with malignant brain tumors who are undergoing surgical resection and brachytherapy treatment with the GliaSite® Radiation Therapy System (RTS).
- Incidence of serious adverse events in patients treated with GliaSite RTS
Read the detailed description
Your doctor has found that you have a brain tumor that needs to be surgically removed. Your doctor has explained the risks and benefits of the surgery. After the brain tumor is surgically removed, some tumor may be left. A treatment that sends additional radiation right to the place around where the tumor was located, may help kill any tumor cells left after the surgery. This treatment is called brachytherapy. Your doctor has explained the risks and benefits of brachytherapy. Researchers in this study would like to evaluate a radiation delivery system, GliaSite RTS, that provides brachytherapy targeted to a specific site in the brain, to see its effects to the surrounding area where the tumor was located.
The GliaSite RTS is a balloon attached to the end of a tube with an access port. The balloon will be put in the space left behind after your tumor is taken out. The end of the tube with its access port will be on the outside of your skull, underneath the skin, at the top of your head. The balloon is filled with radiation therapy solution to provide radiation therapy to any remaining tumor cells next to the space where the tumor was removed.
Before your already scheduled surgery, a series of tests will be performed to find out if you qualify for participation in this study. You will have a complete medical history and your temperature, blood pressure, and pulse will be measured. A standard neurological exam will be performed, in which your mental status, vision, sensory functions, speech, motor skills, and functioning will be evaluated. Women who are able to have children must have a negative urine or blood pregnancy test. A MRI/CT scan will be taken of your head. As part of this MRI/CT, you will get an injection of a contrast solution into your vein. The MRI/CT images will show if there is brain swelling or bleeding. It will also show the edges of the tumor area and will be used to confirm that you should receive radiation therapy with the GliaSite RTS.
If you qualify for the study, you will have a small balloon (GliaSite) placed in the space where the tumor was removed during your surgery. The balloon will be filled with an x-ray dye and normal saline (sterile water with salt) to make sure that the balloon properly fills the space where the tumor was removed. Your surgeon will then stitch your head closed. It is possible that your surgeon may decide not to place the GliaSite device in the space where the tumor was. If your surgeon chooses not to place the GliaSite device, you will be offered alternative treatments, once you recover from surgery.
The balloon will be filled with an x-ray dye solution once it has been placed in the surgical cavity and will be kept filled until it is replaced by the radioactive solution. You will then have an MRI/CT of the head. Following this MRI/CT exam, you will get an injection of a contrast solution into your vein. You will then have a second MRI/CT exam of the head, which will show this contrast solution. The MRI/CT images will show if there is brain swelling or bleeding. It will also show the edges of the tumor area and where the balloon is located. These images will be used to confirm that you should receive radiation therapy with the GliaSite RTS device. You may also have x-ray films of the brain to confirm balloon placement. You may be able to leave the hospital after surgery.
You may be readmitted to the hospital for radiation therapy about one to two weeks after surgery. Twenty-four hours before starting radiation therapy, you will begin taking a medication and continue taking it for 24 hours after your radiation therapy is finished. This medication, an iodine-potassium iodide solution, keeps your thyroid gland from gathering too much radiation in the event that the balloon leaks.
Before the radiation therapy is begun, x-ray films of the brain may be taken to show the location of the balloon and verify the balloon is still properly placed. Once the placement of the balloon is confirmed, the x-ray dye and saline are removed from the catheter. The balloon will then be filled with radiation therapy solution and normal saline.
You may be able to go home once the material has been put into the balloon. If this is done, special instructions will be given to you that you must follow if you are sent home. You must then return to the hospital at the appropriate time for removal of the radioactive material. Otherwise, you will be in the hospital the entire time you are getting radiation therapy.
When the radiation therapy is completed after about 3 to 7 days, the radiation therapy solution will be removed from the balloon. The GliaSite device will be rinsed with normal saline. This rinsing helps lessen any radioactivity remaining in the device. After completion of brachytherapy, the balloon will be completely emptied and the GliaSite device will be surgically removed. When your doctor feels that you are ready, you will be discharged from the hospital.
Following the completion of brachytherapy, you may receive other forms of radiation therapy as prescribed by your physician. This is usually done as an outpatient.
You will be asked to follow up with your doctor at certain time points after you receive the brachytherapy treatment. The time points are 1 month and 3 months after brachytherapy and then every 3 months after that (for example, 1, 3, 6, 9, 12, 15, 18, 21 and 24 months).
During these follow up visits, you will be asked to complete a mini-mental status examination referred to as a MMSE. You will be asked to complete a quality of life questionnaire. Your physician may take an MRI or CT image of your brain if he/she thinks it is necessary.If you have undergone a second operation for your brain cancer, you will be asked about this surgery. You will be asked about any steroid medication you are taking and if the dose has changed since your last visit. Your doctor will also ask you about any other cancer medications or treatments you have received since your last visit.You and your doctor may discuss any serious events that have happened to you since your last visit.
This is an investigational study. The device is FDA approved. About 300 patients will take part in this multicenter study. Up to 20 will be enrolled at M. D. Anderson.
- Conditions
- Brain Tumor
- Being tested
- GliaSite Radiation Therapy System
- Keywords
- Brain Tumor, Radiation Therapy System, GliaSite RTS
- 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
Also called GliaSite RTS
Radiation delivery system that provides brachytherapy targeted to a specific site in the brain, to see its effects to the surrounding area where the tumor was located.
| Study group | Role | What they receive |
|---|---|---|
| GliaSite Radiation Therapy System (RTS) | Experimental | Surgical removal of brain tumor followed by GliaSite RTS targeted brachytherapy to the specific brain tumor site Receives: Device: GliaSite Radiation Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Recurrence of Brain Tumor (anywhere in brain)
Time to recurrence of brain tumor determined for each patient from the time at the end date of brachytherapy with the GliaSite RTS until the date of documented brain tumor recurrence.
Measured: From brachytherapy to assessments at 1 and 3 months after brachytherapy then every 3 months after that or until documented brain tumor recurrence.
Secondary outcomes (1)
Overall Patient Survival
Overall survival determined as time from end date of brachytherapy with the GliaSite RTS until the date of death, including occurrences of death due to CNS causes and by deaths due to non-CNS causes. In the time to event analyses, if the event is not reached, participant censored at last date known to be without the event of interest (recurrence-free or alive). Median time-to-event determined by Kaplan-Meier methods.
Measured: Time from completion of the GliaSite procedure to death by any cause (time in months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2006 (estimated)
- Study startJan 2005
- Primary completionNov 2007
- Study completionJul 2008
Why it stopped: Sponsor decision to terminate study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Mahajan, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415467
- Sponsor's protocol ID
- 2003-0942
- Status last verified
- Aug 2012
- First submitted
- 22 Dec 2006
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV GliaSite® Radiation Therapy System Registry Protocol for the Treatment of Resectable Malignant Brain Tumors
- ClinicalTrials.gov ID
- NCT00415467
- Acronym / sponsor ID
- 2003-0942
- Conditions
- Brain Tumor
- Keywords
- Brain Tumor, Radiation Therapy System, GliaSite RTS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to terminate study.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 25 Dec 2006 (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 goals of this study are to evaluate each of the following items:
- Time to recurrence in patients receiving brachytherapy with the GliaSite RTS
- Overall survival (OS) in patients with malignant brain tumors who are undergoing surgical resection and brachytherapy treatment with the GliaSite® Radiation Therapy System (RTS).
- Incidence of serious adverse events in patients treated with GliaSite RTS
Detailed description
Your doctor has found that you have a brain tumor that needs to be surgically removed. Your doctor has explained the risks and benefits of the surgery. After the brain tumor is surgically removed, some tumor may be left. A treatment that sends additional radiation right to the place around where the tumor was located, may help kill any tumor cells left after the surgery. This treatment is called brachytherapy. Your doctor has explained the risks and benefits of brachytherapy. Researchers in this study would like to evaluate a radiation delivery system, GliaSite RTS, that provides brachytherapy targeted to a specific site in the brain, to see its effects to the surrounding area where the tumor was located.
The GliaSite RTS is a balloon attached to the end of a tube with an access port. The balloon will be put in the space left behind after your tumor is taken out. The end of the tube with its access port will be on the outside of your skull, underneath the skin, at the top of your head. The balloon is filled with radiation therapy solution to provide radiation therapy to any remaining tumor cells next to the space where the tumor was removed.
Before your already scheduled surgery, a series of tests will be performed to find out if you qualify for participation in this study. You will have a complete medical history and your temperature, blood pressure, and pulse will be measured. A standard neurological exam will be performed, in which your mental status, vision, sensory functions, speech, motor skills, and functioning will be evaluated. Women who are able to have children must have a negative urine or blood pregnancy test. A MRI/CT scan will be taken of your head. As part of this MRI/CT, you will get an injection of a contrast solution into your vein. The MRI/CT images will show if there is brain swelling or bleeding. It will also show the edges of the tumor area and will be used to confirm that you should receive radiation therapy with the GliaSite RTS.
If you qualify for the study, you will have a small balloon (GliaSite) placed in the space where the tumor was removed during your surgery. The balloon will be filled with an x-ray dye and normal saline (sterile water with salt) to make sure that the balloon properly fills the space where the tumor was removed. Your surgeon will then stitch your head closed. It is possible that your surgeon may decide not to place the GliaSite device in the space where the tumor was. If your surgeon chooses not to place the GliaSite device, you will be offered alternative treatments, once you recover from surgery.
The balloon will be filled with an x-ray dye solution once it has been placed in the surgical cavity and will be kept filled until it is replaced by the radioactive solution. You will then have an MRI/CT of the head. Following this MRI/CT exam, you will get an injection of a contrast solution into your vein. You will then have a second MRI/CT exam of the head, which will show this contrast solution. The MRI/CT images will show if there is brain swelling or bleeding. It will also show the edges of the tumor area and where the balloon is located. These images will be used to confirm that you should receive radiation therapy with the GliaSite RTS device. You may also have x-ray films of the brain to confirm balloon placement. You may be able to leave the hospital after surgery.
You may be readmitted to the hospital for radiation therapy about one to two weeks after surgery. Twenty-four hours before starting radiation therapy, you will begin taking a medication and continue taking it for 24 hours after your radiation therapy is finished. This medication, an iodine-potassium iodide solution, keeps your thyroid gland from gathering too much radiation in the event that the balloon leaks.
Before the radiation therapy is begun, x-ray films of the brain may be taken to show the location of the balloon and verify the balloon is still properly placed. Once the placement of the balloon is confirmed, the x-ray dye and saline are removed from the catheter. The balloon will then be filled with radiation therapy solution and normal saline.
You may be able to go home once the material has been put into the balloon. If this is done, special instructions will be given to you that you must follow if you are sent home. You must then return to the hospital at the appropriate time for removal of the radioactive material. Otherwise, you will be in the hospital the entire time you are getting radiation therapy.
When the radiation therapy is completed after about 3 to 7 days, the radiation therapy solution will be removed from the balloon. The GliaSite device will be rinsed with normal saline. This rinsing helps lessen any radioactivity remaining in the device. After completion of brachytherapy, the balloon will be completely emptied and the GliaSite device will be surgically removed. When your doctor feels that you are ready, you will be discharged from the hospital.
Following the completion of brachytherapy, you may receive other forms of radiation therapy as prescribed by your physician. This is usually done as an outpatient.
You will be asked to follow up with your doctor at certain time points after you receive the brachytherapy treatment. The time points are 1 month and 3 months after brachytherapy and then every 3 months after that (for example, 1, 3, 6, 9, 12, 15, 18, 21 and 24 months).
During these follow up visits, you will be asked to complete a mini-mental status examination referred to as a MMSE. You will be asked to complete a quality of life questionnaire. Your physician may take an MRI or CT image of your brain if he/she thinks it is necessary.If you have undergone a second operation for your brain cancer, you will be asked about this surgery. You will be asked about any steroid medication you are taking and if the dose has changed since your last visit. Your doctor will also ask you about any other cancer medications or treatments you have received since your last visit.You and your doctor may discuss any serious events that have happened to you since your last visit.
This is an investigational study. The device is FDA approved. About 300 patients will take part in this multicenter study. Up to 20 will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GliaSite Radiation Therapy System (RTS) | Experimental | Device: GliaSite Radiation Therapy SystemSurgical removal of brain tumor followed by GliaSite RTS targeted brachytherapy to the specific brain tumor site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must have histologically proven malignant brain tumor
- Patient must be a candidate for surgical resection of the tumor mass.
- Patient must not be pregnant or breast-feeding. All patients with the potential for pregnancy should be counseled and requested to follow acceptable birth control methods to avoid conception.
- Patient must sign informed consent form
Key exclusion criteria (1 listed)
- 1. Serious concurrent infection or medical illness which could jeopardize the ability of the patient to receive the GliaSite catheter with reasonable safety.
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 SystemAlso: GliaSite RTSRadiation delivery system that provides brachytherapy targeted to a specific site in the brain, to see its effects to the surrounding area where the tumor was located. | Device | GliaSite Radiation Therapy System (RTS) |
Primary outcome
Time to Recurrence of Brain Tumor (anywhere in brain)
Time frame: From brachytherapy to assessments at 1 and 3 months after brachytherapy then every 3 months after that or until documented brain tumor recurrence.
Time to recurrence of brain tumor determined for each patient from the time at the end date of brachytherapy with the GliaSite RTS until the date of documented brain tumor recurrence.
1 secondary outcome
Overall Patient Survival
Time frame: Time from completion of the GliaSite procedure to death by any cause (time in months).
Results and safety
The study was stopped early (reason given: Sponsor decision to terminate study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Anita Mahajan, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GliaSite Radiation Therapy System in people with Brain Tumor, run by M.D. Anderson Cancer Center 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 4 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: stopped early, as of the sponsor's last update on 2 Aug 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 decision to terminate study.). 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?
Time to Recurrence of Brain Tumor (anywhere in brain) (time frame: From brachytherapy to assessments at 1 and 3 months after brachytherapy then every 3 months after that or until documented brain tumor recurrence.). 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 2 Aug 2012.