NCT00031083

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2002

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2002

Completed
1 month until next milestone

Study Start

First participant enrolled

April 2, 2002

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2003

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

First QC Date

February 20, 2002

Last Update Submit

November 13, 2020

Conditions

Glioblastoma MultiformeAnaplastic AstrocytomaOligoastrocytoma, MixedGliosarcoma

Keywords

GliomaBrain TumorAdenovirusGene TherapyBiogen

Interventions

Interferon-betaGENETIC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be greater than or equal to 18 years of age.
  • Subjects must have histologically proven GBM, AA, AMO, malignant astrocytoma NOS or gliosarcoma and recurrent or progressive tumor following prior treatment.
  • Tumor must be amenable to radical resection, and resection must be clinically indicated.
  • Must have an ECOG performance status of 0-2.
  • 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.

You may not qualify if:

  • 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.
  • Brainstem, or optic chiasm involvement of tumor.
  • Uncontrolled seizure disorder.
  • History of a new diagnosis or treatment of an invasive malignancy other than Grade III or Grade IV Glioma within 5 years of enrollment. Curatively treated subjects with a history of basal cell or squamous cell carcinoma of the skin, superficial transitional cell carcinoma of the bladder, and non-invasive carcinoma of the uterine cervix are not excluded.
  • Treatment History:
  • Treatment with radiation therapy, including interstitial radiation or radiosurgery, must be completed at least 8 weeks prior to Day 1.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Arizona at Tucson

Tucson, Arizona, 85724, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 2114, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

GlioblastomaAstrocytomaGliosarcomaGliomaBrain NeoplasmsAdenoviridae Infections

Interventions

Interferon-beta

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2002

First Posted

February 22, 2002

Study Start

April 2, 2002

Study Completion

October 10, 2003

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations

US(5)