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NCT00064779 · ClinicalTrials.gov registry record · Phase 1
Imaging Study of the Distribution of IL13-PE38QQR Infused Before and After Surgery in Adult Patients With Recurrent Malignant Glioma
A Phase 1 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00064779 is a Phase 1 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 18 participants.
The verdict
NCT00064779, a Phase 1 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
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.
Interventions
- PROCEDURE surgery
- DRUG IL13-PE38QQR
- PROCEDURE targeted fusion protein therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2003-07 |
| Est. Completion | 2007-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00064779
The ClinicalTrials.gov registry entry for NCT00064779 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is INSYS Therapeutics, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which surgery is the first listed.
NCT00064779 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00064779 about?
NCT00064779 is a clinical study titled "Imaging Study of the Distribution of IL13-PE38QQR Infused Before and After Surgery in Adult Patients With Recurrent Malignant Glioma". 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 I...
What is the current status of trial NCT00064779?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2003-07. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00064779?
The interventions under investigation include: surgery (PROCEDURE), IL13-PE38QQR (DRUG), targeted fusion protein therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00064779?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
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