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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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.
2. Brainstem, or optic chiasm involvement of tumor. 3. Uncontrolled seizure disorder. 4. 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: 5. Treatment with radiation therapy, including interstitial radiation or radiosurgery, must be completed at least 8 weeks prior to Day 1. 6. Treatment with nitrosoureas must be completed at least 6 weeks prior to Day 1. Treatment with other chemotherapeutic agents must be completed at least 4 weeks prior to Day 1. 7. Treatment with any investigational drug or approved therapy for investigational use must be completed at least 4 weeks prior to Day 1. 8. History of intolerance to corticosteroids that would preclude use during this study, or history of any medical condition that precludes the use of corticosteroids. 9. Any prior treatment with a gene delivery vector, or an adenovirus therapeutic. 10. Women of child bearing potential must have a negative serum pregnancy test. 11. Women who are not postmenopausal, surgically sterile, or willing to practice effective contraception during the study. Men who are not surgically sterile or willing to practice effective contraception during the study. 12. Nursing mothers, pregnant women and women planning to become pregnant while on study. 13. Previous treatment with BG00001.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00031083
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Biogen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Director
Principal Investigator Affiliation Biogen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme, Anaplastic Astrocytoma, Oligoastrocytoma, Mixed, Gliosarcoma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

University of Arizona at Tucson, Tucson, Arizona

Status

Address

University of Arizona at Tucson

Tucson, Arizona, 85724

Denver, Colorado

Status

Address

University of Colorado Health Sciences Center

Denver, Colorado, 80262

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 2114

Philadelphia, Pennsylvania

Status

Address

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104