Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study
I. Determine the toxicities and maximum tolerated dose of IL13-PE38QQR delivered by
continuous infusion into malignant glioma over 96 hours, in two courses eight weeks apart.
II. Estimate the response rate, response duration, time to response, and survival after
interstitial infusion of IL13-PE38QQR into recurrent malignant glioma.
III. Describe the toxicities of interstitial infusion of IL13-PE38QQR at the selected dose.
PROTOCOL OUTLINE: Patients are expected to receive two IL13-PE38QQR infusions at 8-week
intervals. For each course, drug will be infused through each of two catheters; infusion
rate will be held constant during a 96-hour infusion.
In Phase I, the dose of IL13-PE38QQR will be increased by increasing the IL13-PE38QQR
concentration in stepwise fashion, while holding infusion volume and duration constant.
Three patients will be treated at each dose level until the maximum tolerated dose (MTD) is
reached, and an additional three patients are treated at that level. In Phase II, patients
will be treated at the selected MTD.
PROJECTED ACCRUAL: In Phase I, up to 30 patients will be treated. In Phase II, up to 35
patients will be treated.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Jon Weingart, MD
The Johns Hopkins University
United States: Food and Drug Administration
|Wake Forest University||Winston-Salem, North Carolina 27103|
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|
|University of Pennsylvania||Philadelphia, Pennsylvania 19104|
|H. Lee Moffitt Cancer Center||Tampa, Florida 33612|
|Emory University||Atlanta, Georgia 30322|
|The Johns Hopkins University||Baltimore, Maryland 21287|
|Henry Ford Health Systems||Detroit, Michigan 48202|
|Cleveland Clinic||Cleveland, Ohio 44195|