Glioblastoma MultiformeGliadel-MRSNCT00645385
Examination of Changes on Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) in Patients Who Receive Gliadel Wafers During Initial Surgery for Glioblastoma Multiforme. Response or Failure to Gliadel Wafers for Subjects With Glioblastoma Multiforme.
An observational study of Glioblastoma Multiforme and Anaplastic Astrocytoma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Subjects with newly diagnosed brain tumors who undergo surgical resection and whose pathology in the operating room shows a high grade glioma will be eligible. During a screening visit, the study will be discussed, inform consent discussed and signed, a medical history will be taken and a physical examination and… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glioblastoma Multiforme, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma
- What is being tested?
- MRS Spectroscopy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to 1 Jun 2011
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients of >17 years of age.
- Patients with a documented histologic diagnosis of high grade malignant glioma on intraoperative frozen section or squash preparation.
- Solitary, supratentorial lesions that do not cross the midline
- Patients must have a Karnofsky performance status >=60% (or the equivalent ECOG level of 0-2) (see Appendix A; Performance Status Evaluation) and an expected survival of > three months.
- Patients must have adequate hematologic reserve with WBC>=3000/mm3, absolute neutrophils >=1500/mm3 and platelets >=100,000/ mm3.
- Pre-enrollment chemistry parameters must show: bilirubin<1.5X the institutional upper limit of normal (IUNL); AST or ALT<2.5X IUNL and creatinine<1.5X IUNL.
- Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
- Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.
Who cannot join
- Known hypersensitivity or allergy to BCNU (carmustine) or other components of the Gliadel® wafer, such as polifeprosan polymer.
- Multifocal CNS disease
- Diagnosis of prior CNS tumor
- Women who are pregnant or lactating.
- Posterior Fossa or Brain stem tumor
- Open communication of the resection cavity with the ventricular system and tumors that cross the midline.
- Concurrent severe medical (e.g., active infection, acute hepatitis, cardiac arrhythmia, unstable angina, congestive heart failure, uncontrolled diabetes mellitus, uncontrolled seizures, pulmonary insufficiency, pulmonary fibrosis, pulmonary embolus, etc) or psychiatric illness, or abnormal laboratory values that preclude surgical candidacy or limits expected survival to less than 12 weeks. If in doubt, contact the Study Principal Investigator.
- Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College Department of Neurosurgery
New York, New York, 10065
About this study
Official title: Treatment Of Newly Diagnosed, High-Grade, Malignant Glioma With Polifeprosan 20 Containing Carmustine Implant (Gliadel® Wafer) Using MR Spectroscopy Data As A Primary Indicator Of Therapeutic Response.
Subjects with newly diagnosed brain tumors who undergo surgical resection and whose pathology in the operating room shows a high grade glioma will be eligible.
During a screening visit, the study will be discussed, inform consent discussed and signed, a medical history will be taken and a physical examination and laboratory tests will be performed. If these tests are all within acceptable ranges, the subject will be considered for inclusion on this treatment protocol. If the results of any tests are extremely different from normal expected values, she/he may not be able to participate.
Read more
Prior to surgery, the subject will have a contrast enhanced MRI and MRS. The neurosurgeon will attempt to remove the majority of the tumor in the operating room and will send a portion of the specimen removed to the pathologist immediately. This is called a "frozen section". If the pathologist believes that the tumor is a high-grade malignant brain tumor, then the surgeon will place up to 8 dime-sized chemotherapy wafers in the tumor cavity of the brain. The remainder of the tumor specimen will be given to the pathologist to review more closely in the laboratory. If the frozen section does not show that the tumor is a high-grade malignant brain tumor, the subject will not receive the Gliadel wafers and will be removed from the study. The surgeon will then discuss with the subject the appropriate treatment options for the disease he or she has.
During recovery in the hospital, another contrast enhanced MRI will be performed within the first 72 hours after surgery. This is a standard of care for patients who are not involved on this protocol as well. The subject will have another contrast enhanced MRI and MRS performed at the 21st Day after his or her surgery. After Day 21, He or she may begin other forms of treatment. The last contrast enhanced MRI and MRS assessment will be performed 12 weeks after the surgery and the implantation of the Gliadel wafers. Further MRI and MRS may be performed subsequently at the discretion of the doctor.
Throughout the course of treatment, clinical data will be collected.
- Being tested
- MRS Spectroscopy
- Keywords
- GBM, AA, AO, Brain, Tumors, Malignant, Glioblastoma, Multiforme, Carmustine, implant, BCNU, Gliadel, Wafers, MRS, Spectroscopy
- Medical subject headings
- Glioblastoma, Astrocytoma, Oligodendroglioma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRS SpectroscopyOther
Also called MRS, Magnetic Resonance Spectroscopy
Magnetic Resonance Spectroscopy uses a continuous band of radio wave frequencies to excite hydrogen atoms in a variety of chemical compounds other than water. These compounds absorb and emit radio energy at characteristic frequencies, or spectra, that can be used to identify them. Generally, a color image is created by assigning a hue to each distinctive spectral emission. This comprises the "spectroscopy" part of MRS. MRS is still experimental, and is available in only a few research centers.
Physicians mainly use MRS to study the brain and disorders such as epilepsy, Alzheimer's disease, brain tumors, and the effects of drugs on brain growth and metabolism. The technique is also useful in evaluating metabolic disorders of the muscles and nervous system. MRS is a noninvasive scan similar to an MRI that may be done at the same time as an MRI.
| Study group | Role | What they receive |
|---|---|---|
| MRS of the neural system | MRS to study epilepsy, Alzheimer's disease, brain tumors, and the effects of drugs on brain growth and metabolism. Receives: Other: MRS Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stabilization or reduction of tumor on gadolinium enhanced MRI and changes in choline/creatine ratio and NAA on MR Spectroscopy
Measured: June 2011
Secondary outcomes (1)
Median survival, 6-month survival, and progression free survival.
Measured: June 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startJun 2007
- Primary completion1 Jun 2011
- Study completion1 Jun 2011
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.
- More trials run by Weill Medical College of Cornell 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Susan C. Pannullo, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645385
- Sponsor's protocol ID
- 07090991
- Acronym
- Gliadel-MRS
- Status last verified
- May 2019
- First submitted
- 20 Mar 2008
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Of Newly Diagnosed, High-Grade, Malignant Glioma With Polifeprosan 20 Containing Carmustine Implant (Gliadel® Wafer) Using MR Spectroscopy Data As A Primary Indicator Of Therapeutic Response.
- ClinicalTrials.gov ID
- NCT00645385
- Acronym / sponsor ID
- Gliadel-MRS / 07090991
- Keywords
- GBM, AA, AO, Brain, Tumors, Malignant, Glioblastoma, Multiforme
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Jun 2007
- Primary completion
- 1 Jun 2011 (actual)
- Study completion
- 1 Jun 2011 (actual)
- First posted
- 27 Mar 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.
Subjects with newly diagnosed brain tumors who undergo surgical resection and whose pathology in the operating room shows a high grade glioma will be eligible.
During a screening visit, the study will be discussed, inform consent discussed and signed, a medical history will be taken and a physical examination and laboratory tests will be performed. If these tests are all within acceptable ranges, the subject will be considered for inclusion on this treatment protocol. If the results of any tests are extremely different from normal expected values, she/he may not be able to participate.
Prior to surgery, the subject will have a contrast enhanced MRI and MRS. The neurosurgeon will attempt to remove the majority of the tumor in the operating room and will send a portion of the specimen removed to the pathologist immediately. This is called a "frozen section". If the pathologist believes that the tumor is a high-grade malignant brain tumor, then the surgeon will place up to 8 dime-sized chemotherapy wafers in the tumor cavity of the brain. The remainder of the tumor specimen will be given to the pathologist to review more closely in the laboratory. If the frozen section does not show that the tumor is a high-grade malignant brain tumor, the subject will not receive the Gliadel wafers and will be removed from the study. The surgeon will then discuss with the subject the appropriate treatment options for the disease he or she has.
During recovery in the hospital, another contrast enhanced MRI will be performed within the first 72 hours after surgery. This is a standard of care for patients who are not involved on this protocol as well. The subject will have another contrast enhanced MRI and MRS performed at the 21st Day after his or her surgery. After Day 21, He or she may begin other forms of treatment. The last contrast enhanced MRI and MRS assessment will be performed 12 weeks after the surgery and the implantation of the Gliadel wafers. Further MRI and MRS may be performed subsequently at the discretion of the doctor.
Throughout the course of treatment, clinical data will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRS of the neural system | – | Other: MRS SpectroscopyMRS to study epilepsy, Alzheimer's disease, brain tumors, and the effects of drugs on brain growth and metabolism. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients of >17 years of age.
- Patients with a documented histologic diagnosis of high grade malignant glioma on intraoperative frozen section or squash preparation.
- Solitary, supratentorial lesions that do not cross the midline
- Patients must have a Karnofsky performance status >=60% (or the equivalent ECOG level of 0-2) (see Appendix A; Performance Status Evaluation) and an expected survival of > three months.
- Patients must have adequate hematologic reserve with WBC>=3000/mm3, absolute neutrophils >=1500/mm3 and platelets >=100,000/ mm3.
Key exclusion criteria (8 listed)
- Known hypersensitivity or allergy to BCNU (carmustine) or other components of the Gliadel® wafer, such as polifeprosan polymer.
- Multifocal CNS disease
- Diagnosis of prior CNS tumor
- Women who are pregnant or lactating.
- Posterior Fossa or Brain stem tumor
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 |
|---|---|---|
| MRS SpectroscopyAlso: MRS, Magnetic Resonance SpectroscopyMagnetic Resonance Spectroscopy uses a continuous band of radio wave frequencies to excite hydrogen atoms in a variety of chemical compounds other than water. These compounds absorb and emit radio energy at characteristic frequencies, or spectra, that can be used to identify them. Generally, a color image is created by assigning a hue to each distinctive spectral emission. This comprises the "spectroscopy" part of MRS. MRS is still experimental, and is available in only a few research centers. Physicians mainly use MRS to study the brain and disorders such as epilepsy, Alzheimer's disease, brain tumors, and the effects of drugs on brain growth and metabolism. The technique is also useful in evaluating metabolic disorders of the muscles and nervous system. MRS is a noninvasive scan similar to an MRI that may be done at the same time as an MRI. | Other | MRS of the neural system |
Primary outcome
Stabilization or reduction of tumor on gadolinium enhanced MRI and changes in choline/creatine ratio and NAA on MR Spectroscopy
Time frame: June 2011
1 secondary outcome
Median survival, 6-month survival, and progression free survival.
Time frame: June 2011
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
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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.
Susan C. Pannullo, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma Multiforme and Anaplastic Astrocytoma, run by Weill Medical College of Cornell University 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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 4 Jun 2019. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Stabilization or reduction of tumor on gadolinium enhanced MRI and changes in choline/creatine ratio and NAA on MR Spectroscopy (time frame: June 2011). 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 4 Jun 2019; AzTrials last refreshed its copy on 7 Nov 2026.