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Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas

A Multi-center, Open Label, Two Part, Dose Escalation Study to Determine the Tolerability of Interferon-Beta Gene Transfer (BG00001) in the Treatment of Recurrent or Progressive Grade III and Grade IV Gliomas

NCT00031083•Biogen

View on ClinicalTrials.gov

Summary

In this study an investigational replication-defective, recombinant adenovirus expressing the interferon-beta gene (BG00001) will be directly injected into tumors, in patients with recurrent Grade III and Grade IV Gliomas, in order to deliver the hIFN-beta gene. The purpose of the study is to evaluate the safety and any harmful effects of injection of BG00001 into brain tumors. Also, this study will help determine whether the virus carrying the beta interferon gene will enter brain tumor cells and cause the cancer cells to die. This study will require one hospital admission for the actual procedure of drug administration. All other visits will be conducted on an out-patient basis

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Must be greater than or equal to 18 years of age.
•2. Subjects must have histologically proven GBM, AA, AMO, malignant astrocytoma NOS or gliosarcoma and recurrent or progressive tumor following prior treatment.
•3. Tumor must be amenable to radical resection, and resection must be clinically indicated.
•4. Must have an ECOG performance status of 0-2.
•5. Must be on anticonvulsant therapy, and must have therapeutic serum levels within 2 weeks prior to Day 1, if therapeutic levels are defined for the anticonvulsant being used.

Exclusion Criteria

•1. Abnormal blood tests exceeding any of the limits defined below:
•* Alanine transaminase (ALT) \> four times (4X) the upper limit of normal (ULN).
•* Aspartate transaminase (AST) \> 4X the ULN.
•* Total bilirubin \>1.5 mg/dL.
•* Absolute neutrophil count \<1,500 cells/mm3.
•* Platelet count \<100,000 cells/mm3.
•* Serum creatinine \>2X ULN.
•* Prothrombin time (PT) \>2 seconds above the ULN.
•* Serum sodium (Na) \<125 mEq/L or \>150 mEq/L.
•* Serum potassium (K) \<3.5 mEq/L or \> 5.5 mEq/L.
+13 more criteria

Locations (5)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Arizona at Tucson

Tucson, Arizona, United States

University of Colorado Health Sciences Center

Denver, Colorado, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 2, 2002

Completion Date

October 10, 2003

Last Updated

November 17, 2020

Enrollment

Estimated participants

Conditions

Glioblastoma MultiformeAnaplastic AstrocytomaOligoastrocytoma, MixedGliosarcoma

Interventions

Interferon-beta

GENETIC

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITING

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

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