Glioblastoma Multiforme Clinical Trial
Official title:
Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study
IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a
bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a
variety of IL13 receptor-positive tumor cell lines indicating that it may show a therapeutic
benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the
IL13 receptors was shown to be highly specific for human glioma cells.
IL13-PE38QQR will be infused in two courses of 96 hours each, eight weeks apart, directly
into the malignant brain tumors of patients to determine the dose of drug these patients can
tolerate. After that, the selected dose will be studied to give an estimate of the response
rate, response duration, time to response, and survival after infusing that dose of
IL13-PE38QQR into the recurrent malignant glioma.
OBJECTIVES:
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
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