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NCT00024570 · ClinicalTrials.gov registry record · Phase 1
Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma
A Phase 1 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00024570 is a Phase 1 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 60 participants.
The verdict
NCT00024570, a Phase 1 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE surgery
- DRUG IL13-PE38QQR
- PROCEDURE targeted fusion protein therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2000-11 |
| Est. Completion | 2007-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00024570
The ClinicalTrials.gov registry entry for NCT00024570 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 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.
NCT00024570 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00024570 about?
NCT00024570 is a clinical study titled "Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma". 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 comp...
What is the current status of trial NCT00024570?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2000-11. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00024570?
The interventions under investigation include: surgery (PROCEDURE), IL13-PE38QQR (DRUG), targeted fusion protein therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00024570?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
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