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.|
|ClinicalTrials.gov Identifier: NCT00006268|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
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 ClinicalTrials.gov identifier (NCT number): NCT00006268
|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|
|Study Chair:||Jon Weingart, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|