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NCT00089427 · ClinicalTrials.gov registry record · Phase 1
IL13-PE38QQR Infusion After Tumor Resection, Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Malignant Glioma
A Phase 1 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00089427 is a Phase 1 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 24 participants.
The verdict
NCT00089427, a Phase 1 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This Phase 1 study in patients with newly diagnosed malignant glioma is designed to determine the highest dose of IL13-PE38QQR that can be safely administered by Convection Enhanced Delivery (CED) to the area around the tumor site after the tumor is surgically removed (resection). In addition, the patient will receive radiation therapy and may or may not be treated with oral temozolomide.
Interventions
- PROCEDURE Radiation therapy
- DRUG IL13-PE38QQR
- PROCEDURE Surgery for placement
- DRUG Temozolomide with radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2004-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00089427
The ClinicalTrials.gov registry entry for NCT00089427 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 4 interventions - of which Radiation therapy is the first listed.
NCT00089427 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00089427 about?
NCT00089427 is a clinical study titled "IL13-PE38QQR Infusion After Tumor Resection, Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Malignant Glioma". This Phase 1 study in patients with newly diagnosed malignant glioma is designed to determine the highest dose of IL13-PE38QQR that can be safely administered by Convection Enhanced Delivery (CED) to the area around the tumor site after the tumor is surgically removed (resection). In addition, the p...
What is the current status of trial NCT00089427?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2004-07.
What interventions are being tested in trial NCT00089427?
The interventions under investigation include: Radiation therapy (PROCEDURE), IL13-PE38QQR (DRUG), Surgery for placement (PROCEDURE), Temozolomide with radiation therapy (DRUG).
Who is sponsoring clinical trial NCT00089427?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
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