Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma

Phase 1

Completed

• Conditions: Anaplastic Astrocytoma; Glioblastoma Multiforme; Mixed Oligoastrocytoma; Malignant Glioma

• Registration Number: NCT00024570
• Lead Sponsor: INSYS Therapeutics Inc

Brief Summary

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

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.

Study Timeline

• Study Start: 2000-11
• Study First Submitted: 2001-09-20
• Study First Submitted QC: 2001-09-20
• Study First Posted: 2001-09-21
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-12
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (8)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Henry Ford Health Systems; 🇺🇸 Detroit, Michigan, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

The Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

H. Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States