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Imaging Study of the Distribution of IL13-PE38QQR Infused Before and After Surgery in Adult Patients With Recurrent Malignant Glioma

NCT00064779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2011-06-06

No results posted yet for this study

Summary

The experimental anti-cancer drug IL13-PE38QQR, which is being developed for the treatment of malignant brain tumors, is composed of parts of two proteins: the immune system cytokine IL13 and a toxin from the bacterium Pseudomonas aeruginosa. The IL13 part of the drug binds to another protein, the IL13 receptor, when this receptor is displayed on the outside surface of cells. Cells with drug bound to the IL13 receptor take up the drug, and the toxin part of the drug then kills those cells. Since brain tumor cells display the IL13 receptor, they are potential targets that may be killed by this drug. This is a pilot study to visualize the distribution of IL13-PE38QQR infused into and around brain tumor tissue before and after surgical removal of the tumor in adult patients with recurrent malignant glioma.

Stored tumor tissue will be tested for presence of the receptor protein, which is required for study entry. Eligible patients will then undergo biopsy to confirm the diagnosis of recurrent malignant glioma. IL13-PE38QQR will be infused for 96 hours into and around tumor tissue through catheters that have been placed surgically. For the first 48 hours the drug will be mixed with a radioactive tracer, so that the distribution of the drug can be followed by a type of scanning called SPECT. Surgery to remove the tumor will be performed approximately 15 days after the end of the infusion. Catheters will again be placed surgically, and IL13-PE38QQR will be infused a second time for 96 hours. Radioactive tracer will be included in the infusion for the first 48 hours. For both infusions, SPECT scans will be taken at 6, 24, and 48 hours after the start of infusion. MRI scans will be taken within 90 minutes of the 24 and 48 hour SPECT scans. Patients will be followed closely with further scans and laboratory tests until completion of the study approximately 58 days after completion of the second infusion.

Conditions

  • Malignant Glioma
  • Glioblastoma Multiforme
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Mixed Oligoastrocytoma

Interventions

DRUG

IL13-PE38QQR

PROCEDURE

targeted fusion protein therapy

PROCEDURE

surgery

Sponsors & Collaborators

  • INSYS Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2006-06-30
Completion
2007-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00064779 on ClinicalTrials.gov