Glioblastoma MultiformePhase 3NCT00076986
The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme
A Phase 3 study testing IL13-PE38QQR, surgery and catheter placement (2 procedures) and prolifespan 20 with carmustine implant (GLIADEL® Wafer) in people with Glioblastoma Multiforme, run by INSYS Therapeutics Inc at 60 sites in 6 countries.
Trial summary
The purpose of the PRECISE trial is to determine whether overall survival duration, safety, and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GLIADEL® Wafer following surgical tumor removal in the treatment of first recurrence of glioblastoma multiforme. 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?
- IL13-PE38QQR, surgery and catheter placement (2 procedures) and prolifespan 20 with carmustine implant (GLIADEL® Wafer)
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 60 sitesin 6 countries
- Study dates
- Feb 2004to Mar 2007
- Phase
- Phase 3
- 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
- Patients must be ≥ 18 years old.
- Patients must have clinical and/or radiographic evidence of FIRST recurrence or progression of supratentorial GBM afer a previous resection or biopsy and external beam radiation therapy.
- Patients must have histopathologic documentation of GBM at initial diagnosis.
- Patients must have had previous cytoreductive surgery or biopsy for GBM.
- Patients must have received external beam radiotherapy with ≥ 45 Gy tumor dose, completed ≥ 4 weeks prior to study entry.
- Gross total resection (i.e., ≥ 95% resection of the solid, contrast-enhancing tumor component) must be planned.
Show all 16Show fewer
- Tumor must have a solid contrast-enhancing component ≥ 1.0 cm in diameter. Baseline measurements must be obtained ≤ 2 weeks prior to study entry.
- Patients must be in adequate condition, as indicated by:
- Karnofsky Performance Score ≥ 70,
- Adequate hematologic status: i. Absolute neutrophil count (ANC) ≥ 1,500/mm3; ii. Hemoglobin ≥ 10 gm/dL; iii. Platelets ≥ 100,000/mm3; iv. PT and aPTT ≤ 1.5 x institutional upper limit
- Patients must not be receiving concurrent anti-tumor therapy and must have recovered from toxicity of prior therapy. Minimum intervals required:
- ≥ 6 weeks after receiving nitrosourea cytotoxic drug
- ≥ 4 weeks after receiving any non-nitrosourea cytotoxic drug or any systemic investigational agent
- ≥ 2 weeks after receiving any non-cytotoxic anti-tumor drug (including celecoxib or other drugs, if they are being used as anti-tumor therapies)
- Patients must be willing to practice an effective method of birth control during the study. Female patients must not be pregnant or breast-feeding.
- Patients or legal representative must understand the investigational nature of this study and sign a written informed consent form, approved by an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC), prior to performance of any study-specific procedure
Who cannot join
- Patients with contrast-enhancing tumor component crossing the midline, multi-focal tumor not amenable to gross total resection, or tumor dissemination (subependymal or leptomeningeal).
- Expected communication between ventricle and resection cavity that cannot be repaired in order to safely use GLIADEL® Wafer.
- Patients with clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment.
- Patients who have received any type of stereotactic radiosurgery or brachytherapy, with the exception of the stereotactic radiosurgery boost part of the initial fractionated external beam radiation therapy.
- Patients who have received:
- 1) prior treatment with IL13-PE38QQR, or, 2) GLIADEL® Wafer, or, 3) any intracerebral investigational agent
- Patients who have demonstrated a previous hypersensitivity to BCNU or any other component of the GLIADEL® Wafer.
- Patients unwilling or unable to follow protocol requirements.
Trial locations and contacts
60 sites in 6 countries.
60 sites in 6 countries
United States40 sites
Emory University
Atlanta, Georgia, 30322
University of Colorado Hospital - Anschutz Cancer Pavillion
Aurora, Colorado, 80010
The Johns Hopkins University
Baltimore, Maryland, 21287
University of Alabama at Birmingham - Division of Neurosurgery
Birmingham, Alabama, 35294-3410
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Carolina Neurosurgery & Spine Assoc.
Charlotte, North Carolina, 28204
University of Virginia Health Systems - Department of Neurological Surgery
Charlottesville, Virginia, 22908
Northwestern Medical Faculty Foundation, Inc. - Dept of Neurological Surgery
Chicago, Illinois, 60611
CINN at Rush Unversity Medical School
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
Cleveland Clinic Foundation Department of Neurological Surgery
Cleveland, Ohio, 44195
The Ohio State University Medical Center
Columbus, Ohio, 43210
UT Southwestern Medical Center
Dallas, Texas, 75390
Henry Ford Health Systems
Detroit, Michigan, 48202
City of Hope National Medical Center
Duarte, California, 91010-3000
Duke University Medical Center
Durham, North Carolina, 27710
Evanston Northwestern Healthcare
Evanston, Illinois, 60201-1782
Baylor College of Medicine
Houston, Texas, 77030
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Los Angeles County/USC
Los Angeles, California, 90033
Cedars-Sinai Medical Center - Neurological Institute
Los Angeles, California, 90048
University of California - Los Angeles Neuro-Oncology Program
Los Angeles, California, 90095-1769
University of Wisconsin Hospital and Clinic
Madison, Wisconsin, 53792
Baptist Memorial Hospital
Memphis, Tennessee, 38120
West Virginia University Department of Neurosurgery
Morgantown, West Virginia, 26506
Yale University School of Medicine - Department of Neurosurgery
New Haven, Connecticut, 06520
Memorial Sloan Kettering Cancer Center Department of Neurology
New York, New York, 10021
Weill Cornell Medical College - Department of Neurological Surgery
New York, New York, 10021
Columbia University Medical Center - Neurological Institute
New York, New York, 10032
Florida Hospital Neuroscience Institute
Orlando, Florida, 32804
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Huntsman Cancer Insitute
Salt Lake City, Utah, 84132
University of California San Francisco - Dept. of Neurological Surgery
San Francisco, California, 94143
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, 98101
St. Louis University
St Louis, Missouri, 63104
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Wake Forest University Health Sciences - Department of Neurosurgery
Winston-Salem, North Carolina, 27157
Canada8 sites
Calgary Health Region
Calgary, Alberta, T2N 2T9
Walter MacKenzie Health Sciences Center
Edmonton, Alberta, T6G 2B7
London Regional Cancer Center
London, Ontario, N6A 4L6
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5
Toronto Western Hospital Division of Neurosurgery
Toronto
Cancer Care Manitoba
Winnepeg, Manitoba
Germany5 sites
Techniche Universität Dresden Klinik und Poliklinik für Neurochirurgie
Dresden
Universitätsklinikum Hamburg-Eppendorf - Klinik für Neurochirurgie
Hamburg
Klinikum der Universität Heidelberg
Heidelberg
Universitätsklinikum Schleswig-Holstein - Klinik für Neurochirurgie
Kiel, D-24106
Ludwig-Maximilians-Universität München - Klinikum Großhadern - Neurochirurgische Klinik und Poliklinik
München, D-81377
Israel3 sites
Rabin Medical Center - Department of Neurosurgery
Petah Tikva, 49103
Tel Aviv Sourasky Medical Center (TASMC)
Tel Aviv, 64246
Sheba Medical Center - Department of Neurosurgery
Tel HaShomer, 52621
Netherlands2 sites
Academisch Ziekenhuis Groningen Afd. Neurochirurgie
Groningen
Erasmus University MC, Rotterdam
Rotterdam
United Kingdom2 sites
Institute of Neurological Sciences
Glasgow, G51 4TF
The Walton Centre for Neurology & Neurosurgery
Liverpool
About this study
Official title: PRECISE - Phase III Randomized Evaluation of Convection Enhanced Delivery of IL13-PE38QQR Compared to GLIADEL® Wafer With Survival Endpoint in Glioblastoma Multiforme Patients at First Recurrence
The purpose of the PRECISE trial is to determine whether overall survival duration, safety, and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GLIADEL® Wafer following surgical tumor removal in the treatment of first recurrence of glioblastoma multiforme.
Read the detailed description
PRECISE is a Phase III clinical trial of experimental drug IL13-PE38QQR (Study Drug). IL13-PE38QQR is a tumor-targeting agent administered by a continuous infusion directly into the brain around the cavity where the tumor has been removed. Through previous research, this Study Drug has shown potential to control some of the recurrent malignant gliomas, such as glioblastoma multiforme (GBM), anaplastic astrocytoma, and malignant mixed oligoastrocytoma.
The Study Drug is made by combining a human protein (IL13) with a portion of a bacterial toxin protein, Pseudomonas Exotoxin (PE). The IL13 portion binds to receptors on the tumor like a "key to a lock," allowing the PE portion to enter and kill those cells. Since tumor cells preferentially bind the drug, normal (healthy) brain cells are much less likely to be damaged by the drug. The Study Drug is delivered through tubing or catheters placed directly into the area surrounding the resection cavity. These catheters will be surgically placed from 2-7 days after the tumor has been removed. A pump is then used to slowly push the drug solution through the catheters using convection-enhanced delivery (CED) over a period of 4 days.
The GLIADEL® Wafer is an anti-cancer drug that is approved by the U.S. Food and Drug Administration (FDA) and sold for the treatment of recurrent or newly diagnosed GBM. Patients receiving GLIADEL® will have wafers placed at the time of surgery to remove tumor.
Eligible patients enrolled in the PRECISE trial will be randomly assigned to receive either IL13-PE38QQR or GLIADEL® Wafer. Patients will have a 2 out of 3 chance to receive IL13-PE38QQR and 1 out of 3 chance to receive GLIADEL® Wafer.
- Conditions
- Glioblastoma Multiforme
- Being tested
- IL13-PE38QQR, surgery and catheter placement (2 procedures), prolifespan 20 with carmustine implant (GLIADEL® Wafer), surgery and wafer placement (1 procedure)
- Keywords
- brain tumor, recurrent malignant glioma, brain neoplasm, central nervous system, surgery, resection, GLIADEL, infusion, glioblastoma multiforme, convection-enhanced delivery, first recurrence, recurrent GBM, GBM, supratentorial GBM
- Medical subject headings
- Glioblastoma, Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL13-PE38QQRDrug
surgery and catheter placement (2 procedures)Procedure or surgery
prolifespan 20 with carmustine implant (GLIADEL® Wafer)Drug
surgery and wafer placement (1 procedure)Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2004 (estimated)
- Study startFeb 2004
- Primary completionMar 2007
- Study completionMar 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076986
- Sponsor's protocol ID
- IL13PEI-301-R03
- Other IDs
- PRECISE Trial
- Status last verified
- Jun 2011
- First submitted
- 6 Feb 2004
- Last updated
- 6 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRECISE - Phase III Randomized Evaluation of Convection Enhanced Delivery of IL13-PE38QQR Compared to GLIADEL® Wafer With Survival Endpoint in Glioblastoma Multiforme Patients at First Recurrence
- ClinicalTrials.gov ID
- NCT00076986
- Acronym / sponsor ID
- IL13PEI-301-R03
- Conditions
- Glioblastoma Multiforme
- Keywords
- brain tumor, recurrent malignant glioma, brain neoplasm, central nervous system, surgery, resection, GLIADEL, infusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 10 Feb 2004 (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 the PRECISE trial is to determine whether overall survival duration, safety, and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GLIADEL® Wafer following surgical tumor removal in the treatment of first recurrence of glioblastoma multiforme.
Detailed description
PRECISE is a Phase III clinical trial of experimental drug IL13-PE38QQR (Study Drug). IL13-PE38QQR is a tumor-targeting agent administered by a continuous infusion directly into the brain around the cavity where the tumor has been removed. Through previous research, this Study Drug has shown potential to control some of the recurrent malignant gliomas, such as glioblastoma multiforme (GBM), anaplastic astrocytoma, and malignant mixed oligoastrocytoma.
The Study Drug is made by combining a human protein (IL13) with a portion of a bacterial toxin protein, Pseudomonas Exotoxin (PE). The IL13 portion binds to receptors on the tumor like a "key to a lock," allowing the PE portion to enter and kill those cells. Since tumor cells preferentially bind the drug, normal (healthy) brain cells are much less likely to be damaged by the drug. The Study Drug is delivered through tubing or catheters placed directly into the area surrounding the resection cavity. These catheters will be surgically placed from 2-7 days after the tumor has been removed. A pump is then used to slowly push the drug solution through the catheters using convection-enhanced delivery (CED) over a period of 4 days.
The GLIADEL® Wafer is an anti-cancer drug that is approved by the U.S. Food and Drug Administration (FDA) and sold for the treatment of recurrent or newly diagnosed GBM. Patients receiving GLIADEL® will have wafers placed at the time of surgery to remove tumor.
Eligible patients enrolled in the PRECISE trial will be randomly assigned to receive either IL13-PE38QQR or GLIADEL® Wafer. Patients will have a 2 out of 3 chance to receive IL13-PE38QQR and 1 out of 3 chance to receive GLIADEL® Wafer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (16 listed)
- Patients must be ≥ 18 years old.
- Patients must have clinical and/or radiographic evidence of FIRST recurrence or progression of supratentorial GBM afer a previous resection or biopsy and external beam radiation therapy.
- Patients must have histopathologic documentation of GBM at initial diagnosis.
- Patients must have had previous cytoreductive surgery or biopsy for GBM.
- Patients must have received external beam radiotherapy with ≥ 45 Gy tumor dose, completed ≥ 4 weeks prior to study entry.
Key exclusion criteria (8 listed)
- Patients with contrast-enhancing tumor component crossing the midline, multi-focal tumor not amenable to gross total resection, or tumor dissemination (subependymal or leptomeningeal).
- Expected communication between ventricle and resection cavity that cannot be repaired in order to safely use GLIADEL® Wafer.
- Patients with clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment.
- Patients who have received any type of stereotactic radiosurgery or brachytherapy, with the exception of the stereotactic radiosurgery boost part of the initial fractionated external beam radiation therapy.
- Patients who have received:
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 |
|---|---|---|
| IL13-PE38QQR | Drug | – |
| surgery and catheter placement (2 procedures) | Procedure or surgery | – |
| prolifespan 20 with carmustine implant (GLIADEL® Wafer) | Drug | – |
| surgery and wafer placement (1 procedure) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 6 Jun 2011.
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.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IL13-PE38QQR, surgery and catheter placement (2 procedures) and prolifespan 20 with carmustine implant (GLIADEL® Wafer) in people with Glioblastoma Multiforme, run by INSYS Therapeutics Inc at 60 sites in 6 countries.
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 16 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: finished, as of the sponsor's last update on 6 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Canada, Germany, Israel, Netherlands and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 6 Jun 2011.