Glioblastoma MultiformePhase 2NCT00548938
Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM
A Phase 2 study testing Gliadel wafer, Temozolomide and External Beam Radiation Therapy in people with Glioblastoma Multiforme and High-Grade Glioma, run by Methodist Healthcare - Memphis at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of the combination of Gliadel wafers plus surgery and limited field radiation therapy with concomitant temozolomide followed by temozolomide given at an extended dose schedule (metronomic schedule) in patients undergoing initial surgery for… Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Glioblastoma Multiforme, High-Grade Glioma
- What is being tested?
- Gliadel wafer, Temozolomide and External Beam Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2010
- 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 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, must be between ages 18-72
- Patients must have radiographic evidence on cranial magnetic resonance imaging (MRI) of a single, contrast-enhancing unilateral supratentorial cerebral tumor suggestive of high-grade glioma
- Surgical treatment within 4 weeks of the baseline MRI is indicated
- Karnofsky Performance Score of 60 or higher
- Patients must have a pathological diagnosis of high-grade (IV) malignant glioma
- Patients must be willing to use a barrier method of contraception if fertile or if of childbearing potential for up to 2 years after wafer implantation and be counseled regarding the unknown, and potentially harmful, risks to the embryo or fetus while treated on this study
Who cannot join
- Patients who have had prior cytoreductive surgery for high-grade glioma (patients who have had a diagnostic stereotactic biopsy are eligible)
- Patients with more than one focus of tumor or tumor crossing the midline as assessed by coronal cranial MRI scan
- Concomitant significant life-threatening disease from which the patient could reasonably be expected to die within the first 12 months of the study
- Known hypersensitivity reactions to temozolomide, nitrosoureas or any components of the Gliadel wafer
- Prior CNS radiotherapy
- Patients who have received any prior chemotherapy for malignant glioma prior to the baseline evaluation or patients who are currently being treated with chemotherapeutic agents
Show all 12Show fewer
- Patients with fewer than 100,000 platelets per mm3 or fewer than 3,500 leukocytes per mm3
- Liver function tests greater than or equal to 2.5 times the upper limit of normal (transaminases (SGOT, SGPT), total bilirubin, alkaline phosphatase)
- Serum creatinine equal to or greater than 1.5 times the upper limit of normal, blood urea nitrogen (BUN) equal to or greater than 2.5 times the upper limit of normal
- Pregnancy, or lactating females or females of childbearing potential not employing adequate contraception
- Participation in any other investigational protocol in the prior twelve months for any type of malignancy
- Psychological, familial, sociological or geographical conditions which do not permit adequate medical follow-up and compliance with the study protocol
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 of Gliadel, Concomitant Temozolomide and Radiation, Followed by Metronomic Therapy With Temozolomide for Newly Diagnosed Malignant High Grade Glioma
The purpose of this study is to determine the safety and efficacy of the combination of Gliadel wafers plus surgery and limited field radiation therapy with concomitant temozolomide followed by temozolomide given at an extended dose schedule (metronomic schedule) in patients undergoing initial surgery for newly-diagnosed high grade glioma.
Read the detailed description
The patient population in this Phase II clinical trial will be patients with newly diagnosed high-grade glioma undergoing initial surgery. Patients will receive Surgery + Gliadel® wafer implantation + Limited Field Radiation Therapy with concomitant daily temozolomide (75 mg/m2) followed by monthly temozolomide given at the same dose (75 mg/m2 per day for 21 days each month.
Patients will have up to 8 wafers implanted into the tumor resection cavity (depending upon its size) after maximal tumor resection. Between Study Days 14 and 45 all patients will begin a standard course of post-operative limited field radiation therapy to the tumor site and a surrounding margin. Temozolomide will be administered concomitantly with radiation at a daily dose of 75 mg/m2 daily (7 days/week) and then beginning no later than 30 days following completion of radiation therapy on a 75 mg/m2 daily dose given 21 days out of each month for a total of up to 18 cycles.
- Conditions
- Glioblastoma Multiforme, High-Grade Glioma
- Being tested
- Gliadel wafer, Temozolomide, External Beam Radiation Therapy
- Keywords
- Brain Tumor, GBM, Glioblastoma Multiforme, Giladel, Temozolomide
- Medical subject headings
- Glioblastoma, Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gliadel waferDrug
Implanted at surgery
TemozolomideDrug
During External Beam Radiation
External Beam Radiation TherapyRadiation
60 Gy
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of Gliadel wafer + radiation + temozolomide in patients with newly diagnosed high grade glioma undergoing surgery as determined by time to disease progression.
Measured: 2 years
Secondary outcomes (1)
Median, one year and overall survival rate.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2009 (estimated)
- Study completionOct 2010 (estimated)
Why it stopped: Principal Investigator has left the institution
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
- NCT00548938
- Sponsor's protocol ID
- MHIRB #2007-040
- Status last verified
- Sep 2009
- First submitted
- 23 Oct 2007
- 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 II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed by Metronomic Therapy With Temozolomide for Newly Diagnosed Malignant High Grade Glioma
- ClinicalTrials.gov ID
- NCT00548938
- Acronym / sponsor ID
- MHIRB #2007-040
- Conditions
- Glioblastoma Multiforme, High-Grade Glioma
- Keywords
- Brain Tumor, GBM, Glioblastoma Multiforme, Giladel, Temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator has left the institution
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Methodist Healthcare - MemphisUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 24 Oct 2007 (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 safety and efficacy of the combination of Gliadel wafers plus surgery and limited field radiation therapy with concomitant temozolomide followed by temozolomide given at an extended dose schedule (metronomic schedule) in patients undergoing initial surgery for newly-diagnosed high grade glioma.
Detailed description
The patient population in this Phase II clinical trial will be patients with newly diagnosed high-grade glioma undergoing initial surgery. Patients will receive Surgery + Gliadel® wafer implantation + Limited Field Radiation Therapy with concomitant daily temozolomide (75 mg/m2) followed by monthly temozolomide given at the same dose (75 mg/m2 per day for 21 days each month.
Patients will have up to 8 wafers implanted into the tumor resection cavity (depending upon its size) after maximal tumor resection. Between Study Days 14 and 45 all patients will begin a standard course of post-operative limited field radiation therapy to the tumor site and a surrounding margin. Temozolomide will be administered concomitantly with radiation at a daily dose of 75 mg/m2 daily (7 days/week) and then beginning no later than 30 days following completion of radiation therapy on a 75 mg/m2 daily dose given 21 days out of each month for a total of up to 18 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women, must be between ages 18-72
- Patients must have radiographic evidence on cranial magnetic resonance imaging (MRI) of a single, contrast-enhancing unilateral supratentorial cerebral tumor suggestive of high-grade glioma
- Surgical treatment within 4 weeks of the baseline MRI is indicated
- Karnofsky Performance Score of 60 or higher
- Patients must have a pathological diagnosis of high-grade (IV) malignant glioma
Key exclusion criteria (12 listed)
- Patients who have had prior cytoreductive surgery for high-grade glioma (patients who have had a diagnostic stereotactic biopsy are eligible)
- Patients with more than one focus of tumor or tumor crossing the midline as assessed by coronal cranial MRI scan
- Concomitant significant life-threatening disease from which the patient could reasonably be expected to die within the first 12 months of the study
- Known hypersensitivity reactions to temozolomide, nitrosoureas or any components of the Gliadel wafer
- Prior CNS radiotherapy
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 |
|---|---|---|
| Gliadel waferImplanted at surgery | Drug | – |
| TemozolomideDuring External Beam Radiation | Drug | – |
| External Beam Radiation Therapy60 Gy | Radiation | – |
Primary outcome
To determine the efficacy of Gliadel wafer + radiation + temozolomide in patients with newly diagnosed high grade glioma undergoing surgery as determined by time to disease progression.
Time frame: 2 years
1 secondary outcome
Median, one year and overall survival rate.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Principal Investigator has left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
Related trials for Glioblastoma Multiforme
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
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 2 study testing Gliadel wafer, Temozolomide and External Beam Radiation Therapy in people with Glioblastoma Multiforme and High-Grade Glioma, 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 6 inclusion and 12 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 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: Principal Investigator has left the institution). 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 determine the efficacy of Gliadel wafer + radiation + temozolomide in patients with newly diagnosed high grade glioma undergoing surgery as determined by time to disease progression. (time frame: 2 years). 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.