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.
Sponsor:
Information provided by:
INSYS Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00089427
First received: August 5, 2004
Last updated: June 30, 2011
Last verified: April 2011
  Purpose

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
Oligoastrocytoma
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)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089427

Locations
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

ClinicalTrials.gov 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
surgery
resection
temozolomide
infusion
glioblastoma multiforme
anaplastic astrocytoma
oligoastrocytoma
Temodar
radiation
convection-enhanced delivery
GBM

Additional relevant MeSH terms:
Astrocytoma
Glioblastoma
Glioma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014