Interstitial Infusion of IL 13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study
- 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
Primary Purpose: Treatment
Jon Weingart, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Abramson Cancer Center at the University of Pennsylvania||Philadelphia, Pennsylvania 19104|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Josephine Ford Cancer Center at Henry Ford Health System||Detroit, Michigan 48202|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida||Tampa, Florida 33612|
|National Institute of Neurological Disorders and Stroke||Bethesda, Maryland 20892-1414|