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Immunotoxin Therapy in Treating Patients With Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006268
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for malignant glioma.

PURPOSE: Phase I/II trial to study the effectiveness of immunotoxin therapy in treating patients who have malignant glioma.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Biological: cintredekin besudotox Drug: isolated perfusion Procedure: conventional surgery Phase 1 Phase 2

Detailed Description:


  • Determine the toxic effects and maximum tolerated dose (MTD) of interstitial interleukin-13 PE38QQR immunotoxin in patients with malignant glioma.
  • Determine the response rate, duration of response, time to response, overall survival, and time to progression in patients treated with this regimen.
  • Determine the toxic effects of this drug at the MTD in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients undergo stereotactic biopsy of brain tumor followed by CT guided stereotactic placement of 2 intratumoral catheters on day 0. Patients with histologically confirmed malignant glioma receive interleukin-13 PE38QQR immunotoxin interstitially over 96 hours beginning on day 1. Patients with a residual enhancing mass undergo repeat catheter placement on day 56 and then receive a second interstitial infusion beginning on day 57 in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of interleukin-13 PE38QQR immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD.

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for phase I of the study within 6 months and a total of 12-35 patients will be accrued for phase II of the study within 10-12 months.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Interstitial Infusion of IL 13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study
Study Start Date : October 2000
Actual Study Completion Date : March 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven malignant glioma (grade 3 or 4)

    • Anaplastic astrocytoma
    • Glioblastoma multiforme
    • Malignant mixed oligoastrocytoma
  • Must have undergone cranial radiotherapy with tumor dose of at least 48 Gy and at least 12 weeks prior to study
  • Must have undergone supratentorial brain tumor surgery or biopsy
  • Must have radiographic evidence of recurrent or progressive supratentorial tumor compared with prior study

    • Must have solid portion measuring 1.0-5.0 cm in maximum diameter
    • Maximum of 1 satellite lesion allowed if separated from the primary mass by less than 3 cm
    • No tumor crossing the midline
    • No leptomeningeal tumor dissemination
    • No impending herniation or spinal cord compression
  • No uncontrolled seizures



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Hemoglobin at least 10 g/dL
  • Platelet count at least 100,000/mm^3


  • PT and PTT no greater than upper limit of normal (ULN)
  • SGOT and SGPT no greater than 2.5 times ULN
  • Bilirubin no greater than 2.0 mg/dL


  • Not specified


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer


Biologic therapy:

  • Not specified


  • No prior intralesional chemotherapy for malignant glioma
  • At least 3 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas) and recovered
  • No concurrent chemotherapy

Endocrine therapy:

  • Concurrent corticosteroids allowed, but dose must remain stable or be tapered during study


  • See Disease Characteristics
  • No prior focal radiotherapy (e.g., any form of stereotactic radiotherapy or brachytherapy) for malignant glioma


  • See Disease Characteristics


  • Recovered from any prior therapy
  • No other concurrent investigational agent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006268

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United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
National Institute of Neurological Disorders and Stroke
Bethesda, Maryland, United States, 20892-1414
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Pennsylvania
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
Sponsors and Collaborators
New Approaches to Brain Tumor Therapy Consortium
National Cancer Institute (NCI)
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Study Chair: Jon Weingart, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Layout table for additonal information Identifier: NCT00006268     History of Changes
Other Study ID Numbers: CDR0000068211
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: March 2005

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases