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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: Completed Phase 1 study, sponsored by INSYS Therapeutics.

NCT00089427 is a Phase 1 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 24 participants
Start Date 2004-07
Phase Phase 1
INSYS Therapeutics

35 total trials

What the finished NCT00089427 record still lists

NCT00089427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 4 interventions - of which Radiation therapy is the first listed.

NCT00089427 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00089427's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00089427, the US trial registry maintained by the National Library of Medicine. NCT00089427 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.