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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00031083
First received: February 20, 2002
Last updated: June 7, 2012
Last verified: November 2004
  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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Estimated Enrollment: 35
Study Start Date: January 2002
Estimated Study Completion Date: March 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031083

Locations
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
Biogen Idec
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00031083     History of Changes
Obsolete Identifiers: NCT00036725
Other Study ID Numbers: C-1502, 0101-453
Study First Received: February 20, 2002
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Glioma
Brain Tumor
Adenovirus
Gene Therapy
Biogen

Additional relevant MeSH terms:
Astrocytoma
Glioblastoma
Glioma
Gliosarcoma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Interferon-beta
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 29, 2014