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| Sponsored by: |
Biogen Idec |
|---|---|
| Information provided by: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00031083 |
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 |
Gene Transfer: Interferon-beta |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Abnormal blood tests exceeding any of the limits defined below:
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:
Contacts and 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, 02114 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
More Information
| Study ID Numbers: | C-1502, 0101-453 |
| Study First Received: | February 20, 2002 |
| Last Updated: | June 7, 2006 |
| ClinicalTrials.gov Identifier: | NCT00031083 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Glioma Brain Tumor Adenovirus Gene Therapy Biogen |
|
Glioblastoma Immunologic Factors Astrocytoma Adenoviridae Infections Interferons Interferon-beta Antiviral Agents Recurrence |
Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Glioblastoma Multiforme Gliosarcoma Neoplasms, Glandular and Epithelial |
|
Anti-Infective Agents Glioblastoma Neoplasms by Histologic Type Immunologic Factors Astrocytoma Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Interferons Interferon-beta |
Antiviral Agents Pharmacologic Actions Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Gliosarcoma Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |