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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00031083
Recruitment Status : Suspended
First Posted : February 22, 2002
Last Update Posted : June 8, 2012
Information provided by:

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

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Anaplastic Astrocytoma Oligoastrocytoma, Mixed Gliosarcoma Genetic: Interferon-beta Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2002
Study Completion Date : March 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00031083

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
University of Arizona at Tucson
Tucson, Arizona, United States, 85724
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 2114
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators

Layout table for additonal information Identifier: NCT00031083    
Obsolete Identifiers: NCT00036725
Other Study ID Numbers: C-1502
First Posted: February 22, 2002    Key Record Dates
Last Update Posted: June 8, 2012
Last Verified: November 2004
Keywords provided by Biogen:
Brain Tumor
Gene Therapy
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs