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Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma

NCT ID: NCT00024570

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malignant Glioma Glioblastoma Multiforme Anaplastic Astrocytoma Mixed Oligoastrocytoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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IL13-PE38QQR

Intervention Type DRUG

targeted fusion protein therapy

Intervention Type PROCEDURE

surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Female patients must not be pregnant or breast-feeding.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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INSYS Therapeutics Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Jon Weingart, MD

Role: STUDY_CHAIR

The Johns Hopkins University

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

The Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Henry Ford Health Systems

Detroit, Michigan, United States

Site Status

Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-NABTT-9903

Identifier Type: -

Identifier Source: secondary_id

JHU-NABTT-9903

Identifier Type: -

Identifier Source: secondary_id

IL13PEI-001

Identifier Type: -

Identifier Source: org_study_id