The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme

Completed · Phase 3

Conditions studied: Glioblastoma Multiforme

In brief

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.

Key facts

Study ID

NCT00076986

Run by

INSYS Therapeutics Inc

People needed

300

Starts

2004-02-01

Expected to finish

2007-03-01

Last updated by the study team

2011-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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

You may not qualify if…

• 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:
• 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.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Los Angeles County/USC — Los Angeles, California, United States
• Cedars-Sinai Medical Center - Neurological Institute — Los Angeles, California, United States
• University of California - Los Angeles Neuro-Oncology Program — Los Angeles, California, United States
• University of California San Francisco - Dept. of Neurological Surgery — San Francisco, California, United States
• University of Colorado Hospital - Anschutz Cancer Pavillion — Aurora, Colorado, United States
• Yale University School of Medicine - Department of Neurosurgery — New Haven, Connecticut, United States
• Florida Hospital Neuroscience Institute — Orlando, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern Medical Faculty Foundation, Inc. - Dept of Neurological Surgery — Chicago, Illinois, United States
• CINN at Rush Unversity Medical School — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Evanston Northwestern Healthcare — Evanston, Illinois, United States
• The Johns Hopkins University — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Henry Ford Health Systems — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St. Louis University — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center Department of Neurology — New York, New York, United States
• Weill Cornell Medical College - Department of Neurological Surgery — New York, New York, United States
• Columbia University Medical Center - Neurological Institute — New York, New York, United States
• Carolina Neurosurgery & Spine Assoc. — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Alabama at Birmingham - Division of Neurosurgery — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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