IL13-PE38QQR Infusion After Tumor Resection, Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Malignant Glioma

This study has been completed.
Information provided by:
INSYS Therapeutics Inc Identifier:
First received: August 5, 2004
Last updated: June 30, 2011
Last verified: April 2011

This Phase 1 study in patients with newly diagnosed malignant glioma is designed to determine the highest dose of IL13-PE38QQR that can be safely administered by Convection Enhanced Delivery (CED) to the area around the tumor site after the tumor is surgically removed (resection). In addition, the patient will receive radiation therapy and may or may not be treated with oral temozolomide.

Condition Intervention Phase
Glioblastoma Multiforme
Anaplastic Astrocytoma
Drug: IL13-PE38QQR
Procedure: Surgery for placement
Procedure: Radiation therapy
Drug: Temozolomide with radiation therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Convection Enhanced Delivery (CED) of IL13-PE38QQR Infusion After Resection Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma

Resource links provided by NLM:

Further study details as provided by INSYS Therapeutics Inc:

Estimated Enrollment: 24
Study Start Date: July 2004
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must be ≥18 years old.
  • Patients must have undergone a gross total resection of the solid contrast-enhancing lesion(s) > 1.0 cm in diameter.
  • Patients must be able to have catheters placed within 14 days of tumor resection (including a planned Gross Total Resection following an initial biopsy or subtotal resection)
  • Patients must have histopathologic confirmation of malignant glioma from resection specimen. Diagnosis must be consistent with either GBM, AA, or malignant mixed OA.
  • Patients must be in adequate general condition and meet the following criteria:
  • a. Karnofsky Performance Scale score ≥ 70
  • b. Adequate hematologic status:

    • Absolute neutrophil count ≥ 1,500/mm³
    • Hemoglobin ≥ 10 gm/dL
    • Platelets ≥ 100,000/mm³
    • PT & aPTT within institutional limits of normal
  • Female patients must not be pregnant or breast-feeding.
  • Patients must practice an effective method of birth control during the study and for 60 days beyond the last day of infusion.
  • Patients must understand the investigational nature of this study and its potential risks and benefits, and sign an approved written informed consent prior to performance of any study-specific procedure.

Exclusion Criteria:

  • Patients with residual contrast-enhancing tumor crossing the midline, multifocal tumor not amenable to gross total resection or non-parenchymal tumor dissemination (e.g., subependymal or leptomeningeal).
  • Patients with clinically significant increased ICP (e.g., impending herniation), uncontrolled seizures or requirement for immediate palliative treatment.
  • Patients who have received any prior anti-tumor treatment (other than corticosteroids) including any investigational agents.
  • Patients with any metallic prosthesis that would prevent MRI and/or MRS scanning procedures of the brain.
  • Patients unwilling or unable to follow protocol requirements.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00089427

United States, California
University of California San Francisco - Dept. of Neurological Surgery
San Francisco, California, United States, 94143
United States, North Carolina
Carolina Neurosurgery & Spine Assoc.
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation Department of Neurological Surgery
Cleveland, Ohio, United States, 44195
United States, Texas
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Health Systems - Department of Neurological Surgery
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
INSYS Therapeutics Inc
  More Information

No publications provided Identifier: NCT00089427     History of Changes
Obsolete Identifiers: NCT00105014
Other Study ID Numbers: IL13PEI-106-R01
Study First Received: August 5, 2004
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by INSYS Therapeutics Inc:
brain tumor
malignant glioma
brain neoplasm
central nervous system
glioblastoma multiforme
anaplastic astrocytoma
convection-enhanced delivery

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on October 07, 2015