Glioblastoma MultiformePhase 1/2NCT00376103
Radiation Boost for Newly Diagnosed Glioblastoma Multiforme
A Phase 1/2 study testing temozolomide, Brachytherapy and External Beam Radiation Therapy in people with Glioblastoma Multiforme, run by Methodist Healthcare - Memphis at 1 site in United States.
Trial summary
The purpose of this study is to determine treatment related toxicity, tumor response, progression-free survival and quality of life of newly diagnosed Glioblastoma Multiforme (GBM) patients undergoing a combination of surgical resection, brachytherapy and external beam radiation with concomitant temozolomide, followed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- temozolomide, Brachytherapy and External Beam Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Mar 2008
- Phase
- Phase 1/2
- 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
- Newly diagnosed, unifocal, unilateral, supratentorial lesion seen on MRI and suspicious for Glioblastoma Multiforme
- Subject must be a candidate for surgical resection of the tumor mass with feasible gross total resection
- Age 18 years or older
- Subject must be an appropriate candidate to receive brachytherapy and temozolomide per the GliaSite RTS and temozolomide IFU
- The tumor must be histopathologically confirmed by intra-operative frozen section and by final pathology
- Karnofsky Performance Status (KPS) => 70
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- Negative pregnancy test if a female of childbearing age and not surgically sterilized
- Male or female subject agrees to use acceptable birth control methods while receiving treatment (if not surgically sterile)
- Life expectancy > 3 months
- Adequate laboratory results: ANC => 1.5 x 109/L. Platelets => 100 x 109/L
- Subject or legal representative must provide informed consent and HIPAA authorization prior to surgery
Who cannot join
- Prior use of temozolomide
- Presence or history of severe hepatic or renal impairment
- Subject cannot tolerate temozolomide therapy due to NPO status or intractable nausea and vomiting
- Subject with prior intracranial malignancy
- Major medical illness or psychiatric impairments that in the investigators opinion will prevent administration or completion of the protocol therapy
- Subject has pacemaker or other MRI non-compatible metal in the body
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- Previous radiation to the head/neck or brain
- Pregnant or lactating women
- Patient has allergy to iodine and/or dacarbazine
- Creatinine > 1.5x upper limits of normal (ULN), AST > 3x ULN
- Chemotherapy within the last 6 months
- Residual tumor >1 cm (in a single dimension) on baseline MRI scan (T1 post-gadolinium images)
- Balloon surface within 1 cm of critical structure (brain stem, midbrain, optic chiasm) on baseline MRI scan
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 I/II Trial of Maximal Resection, Local Radiation Boost With Concomitant Temozolomide, Followed by External Radiation Therapy With Concomitant Temozolomide for the Treatment of Newly Diagnosed Glioblastoma Multiforme
The purpose of this study is to determine treatment related toxicity, tumor response, progression-free survival and quality of life of newly diagnosed Glioblastoma Multiforme (GBM) patients undergoing a combination of surgical resection, brachytherapy and external beam radiation with concomitant temozolomide, followed by adjuvant temozolomide.
Read the detailed description
The study design is multi-centered and non-randomized. Patients with newly diagnosed GBM undergoing initial surgical resection will be candidates for this study. Eligible patients will undergo surgical resection within 30 days of diagnosis.
Newly diagnosed patients with presumed diagnosis of GBM will undergo surgery for maximal resection. After frozen section diagnosis of GBM is confirmed, the GliaSite® will be placed into the tumor cavity.
After the patient recovers from surgery, radiation therapy (60 Gy to 1 cm) is delivered via the GliaSite®. Radiation therapy with the GliaSite® will be initiated within 21 days after surgery. Concomitant temozolomide (75 mg/m2/d) is started 2 days prior to radiation therapy with the GliaSite® and continued for a total of 7 days.
Within 21 days following radiation therapy with the GliaSite®, external beam radiation therapy (60 Gy in 30 fractions) will be initiated. Concomitant temozolomide (75 mg/m2/d) will start on day 1 of external beam radiation therapy and continue through the external beam radiation therapy interval, ending with the last day of radiation.
Four weeks (+/- 2 days) after completion of external beam radiation therapy, temozolomide (150 mg/m2/d) for 5 days every 28 days will be initiated for one cycle.
At the start of cycle 2, the dose will be escalated to 200 mg/m2/d, if the CTC non-hematological toxicity for cycle 1 is Grade < 2 (except for alopecia, nausea and vomiting).
This will continue for up to a total of 12 cycles, unless disease progression or severe myelosuppression is noted.
- Conditions
- Glioblastoma Multiforme
- Being tested
- temozolomide, Brachytherapy, External Beam Radiation Therapy
- Keywords
- Brain Tumor, GBM, Glioblastoma Multiforme, Glioblastoma, Brachytherapy, Temozolomide, Temodar
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
Also called Temodar
75 mg/m2/day
BrachytherapyProcedure or surgery
60 Gy to 1 cm
External Beam Radiation TherapyProcedure or surgery
60 Gy
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related toxicity.
Measured: 1 year
Secondary outcomes (4)
6 month, 1 year and overall survival.
Measured: End of study
Tumor progression.
Measured: End of study
Progression-free survival.
Measured: End of study
Quality of life.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startAug 2006
- Primary completionMar 2008
Why it stopped: Loss of funding from sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Healthcare - Memphis
- Sponsor type
- University, hospital or other
- Investigators
- Allen K Sills, MD, Principal investigator, Methodist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376103
- Sponsor's protocol ID
- MHIRB 2006-032
- Status last verified
- Sep 2009
- First submitted
- 13 Sep 2006
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Maximal Resection, Local Radiation Boost With Concomitant Temozolomide, Followed by External Radiation Therapy With Concomitant Temozolomide for the Treatment of Newly Diagnosed Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00376103
- Acronym / sponsor ID
- MHIRB 2006-032
- Conditions
- Glioblastoma Multiforme
- Keywords
- Brain Tumor, GBM, Glioblastoma Multiforme, Glioblastoma, Brachytherapy, Temozolomide, Temodar
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding from sponsor
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Methodist Healthcare - MemphisUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Mar 2008 (actual)
- First posted
- 14 Sep 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 purpose of this study is to determine treatment related toxicity, tumor response, progression-free survival and quality of life of newly diagnosed Glioblastoma Multiforme (GBM) patients undergoing a combination of surgical resection, brachytherapy and external beam radiation with concomitant temozolomide, followed by adjuvant temozolomide.
Detailed description
The study design is multi-centered and non-randomized. Patients with newly diagnosed GBM undergoing initial surgical resection will be candidates for this study. Eligible patients will undergo surgical resection within 30 days of diagnosis.
Newly diagnosed patients with presumed diagnosis of GBM will undergo surgery for maximal resection. After frozen section diagnosis of GBM is confirmed, the GliaSite® will be placed into the tumor cavity.
After the patient recovers from surgery, radiation therapy (60 Gy to 1 cm) is delivered via the GliaSite®. Radiation therapy with the GliaSite® will be initiated within 21 days after surgery. Concomitant temozolomide (75 mg/m2/d) is started 2 days prior to radiation therapy with the GliaSite® and continued for a total of 7 days.
Within 21 days following radiation therapy with the GliaSite®, external beam radiation therapy (60 Gy in 30 fractions) will be initiated. Concomitant temozolomide (75 mg/m2/d) will start on day 1 of external beam radiation therapy and continue through the external beam radiation therapy interval, ending with the last day of radiation.
Four weeks (+/- 2 days) after completion of external beam radiation therapy, temozolomide (150 mg/m2/d) for 5 days every 28 days will be initiated for one cycle.
At the start of cycle 2, the dose will be escalated to 200 mg/m2/d, if the CTC non-hematological toxicity for cycle 1 is Grade < 2 (except for alopecia, nausea and vomiting).
This will continue for up to a total of 12 cycles, unless disease progression or severe myelosuppression is noted.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Newly diagnosed, unifocal, unilateral, supratentorial lesion seen on MRI and suspicious for Glioblastoma Multiforme
- Subject must be a candidate for surgical resection of the tumor mass with feasible gross total resection
- Age 18 years or older
- Subject must be an appropriate candidate to receive brachytherapy and temozolomide per the GliaSite RTS and temozolomide IFU
- The tumor must be histopathologically confirmed by intra-operative frozen section and by final pathology
Key exclusion criteria (13 listed)
- Prior use of temozolomide
- Presence or history of severe hepatic or renal impairment
- Subject cannot tolerate temozolomide therapy due to NPO status or intractable nausea and vomiting
- Subject with prior intracranial malignancy
- Major medical illness or psychiatric impairments that in the investigators opinion will prevent administration or completion of the protocol therapy
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 |
|---|---|---|
| temozolomideAlso: Temodar75 mg/m2/day | Drug | – |
| Brachytherapy60 Gy to 1 cm | Procedure or surgery | – |
| External Beam Radiation Therapy60 Gy | Procedure or surgery | – |
Primary outcome
Treatment-related toxicity.
Time frame: 1 year
4 secondary outcomes
6 month, 1 year and overall survival.
Time frame: End of study
Tumor progression.
Time frame: End of study
Progression-free survival.
Time frame: End of study
Quality of life.
Time frame: End of study
Results and safety
The study was stopped early (reason given: Loss of funding from sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
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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, MD principal investigator
Methodist 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 1/2 study testing temozolomide, Brachytherapy and External Beam Radiation Therapy in people with Glioblastoma Multiforme, run by Methodist Healthcare - Memphis 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 11 inclusion and 13 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 18 Sep 2009. 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 combined 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.
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: Loss of funding from sponsor). 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?
Treatment-related toxicity. (time frame: 1 year). 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 18 Sep 2009.