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NCT00528684 · ClinicalTrials.gov registry record · Phase 1

Safety and Efficacy Study of REOLYSIN® in the Treatment of Recurrent Malignant Gliomas

A Phase 1 study of Malignant Glioma, sponsored by Oncolytics Biotech.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target
3
Study locations

NCT00528684 is a Phase 1 study of Malignant Glioma that has completed, run by Oncolytics Biotech. The registered enrollment target is 18 participants, below the 91-participant average among 40 other Malignant Glioma trials with a reported enrollment target (80% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT00528684, a Phase 1 study of Malignant Glioma, has completed, sponsored by Oncolytics Biotech.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target
3
Study locations

Study Summary

RATIONALE: Oncolytic viruses such as reovirus (REOLYSIN®) can specifically kill tumor cells while leaving healthy cells unharmed. PURPOSE: This phase I/II study investigates the maximum tolerated dose (MTD), dose limiting toxicity (DLT) and anti-tumor effect of intralesional administration of REOLYSIN® therapeutic reovirus in patients with malignant glioma with evaluable disease which is progressive/recurrent despite surgery and/or radiotherapy with or without chemotherapy. (The phase I portion of the study is currently enrolling patients.)

Conditions Studied

Malignant Glioma

Interventions

  • BIOLOGICAL REOLYSIN®

Study Locations (3)

Alabama

  • University of Alabama at Birmingham - Birmingham

California

  • Cedars-Sinai Medical Center - Los Angeles

Ohio

  • The Ohio State University Medical Center and Arthur G. James Cancer Hospital and Richard J. Solove Research Center - Columbus

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2006-07
Est. Completion 2010-06
Phase Phase 1

Sponsor

Oncolytics Biotech

12 total trials

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What the Registry Record Tells You About NCT00528684

The ClinicalTrials.gov registry entry for NCT00528684 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, below the 91-participant average among 40 other Malignant Glioma trials with a reported enrollment target (80% lower). The listed sponsor is Oncolytics Biotech, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Malignant Glioma appearing as the primary indexed condition, and to 1 intervention - of which REOLYSIN® is the first listed.

NCT00528684 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Alabama, California, Ohio.

Frequently Asked Questions

What is clinical trial NCT00528684 about?

NCT00528684 is a clinical study titled "Safety and Efficacy Study of REOLYSIN® in the Treatment of Recurrent Malignant Gliomas". RATIONALE: Oncolytic viruses such as reovirus (REOLYSIN®) can specifically kill tumor cells while leaving healthy cells unharmed. PURPOSE: This phase I/II study investigates the maximum tolerated dose (MTD), dose limiting toxicity (DLT) and anti-tumor effect of intralesional administration of REOLY...

What is the current status of trial NCT00528684?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2006-07. Estimated completion is 2010-06.

What conditions does trial NCT00528684 study?

This clinical trial studies the following conditions: Malignant Glioma.

What interventions are being tested in trial NCT00528684?

The interventions under investigation include: REOLYSIN® (BIOLOGICAL).

Who is sponsoring clinical trial NCT00528684?

This trial is sponsored by Oncolytics Biotech, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00528684 being conducted?

This trial has 3 study locations across Alabama, California, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.