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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 Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas Clinical research trials and Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas. Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas clinical trial. Test subjects typically receive the most effective healthcare possible for their Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas  Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas
Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas
For Condition: Anaplastic Astrocytoma,Glioblastoma Multiforme,Oligoastrocytoma, Mixed,Gliosarcoma
Status: Suspended
Sponsor(s): Biogen Idec ,
Synopsis: 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
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 35
Location and Contact Information:
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
University of Arizona at Tucson
Tucson, Arizona, 85724
United States
Additional Information:
Study ID Numbers: C-1502; 0101-453
Study Start Date: January 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031083
Other Gliosarcoma Studies:
1. Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas
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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
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