|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | 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 |
Genetic: Interferon-beta |
Phase I |
| 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 |
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, 2114 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00031083 History of Changes |
| Other Study ID Numbers: | C-1502, 0101-453 |
| Study First Received: | February 20, 2002 |
| Last Updated: | September 16, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Glioma Brain Tumor Adenovirus Gene Therapy Biogen |
|
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 |