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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006268 |
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 | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Biological: cintredekin besudotox Drug: isolated perfusion Procedure: conventional surgery |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Interstitial Infusion of IL 13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study |
Study Start Date: | October 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven malignant glioma (grade 3 or 4)
Must have radiographic evidence of recurrent or progressive supratentorial tumor compared with prior study
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 | |
National Institute of Neurological Disorders and Stroke | |
Bethesda, Maryland, United States, 20892-1414 | |
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 | |
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 |
Study Chair: | Jon Weingart, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000068211, NABTT-9903, JHOC-NABTT-9903, NEOPHARM-TS-G1-TI4, NEOPHARM-IL13PEI-001-R03 |
Study First Received: | September 11, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00006268 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma |
adult mixed glioma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Central Nervous System Neoplasms Recurrence Immunotoxins Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Nervous System Diseases |
Neoplasms, Nerve Tissue Central Nervous System Neoplasms Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |