Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade… (NCT00031083) | Clinical Trial Compass
CompletedPhase 1
Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas
United States12 participantsStarted 2002-04-02
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Must be greater than or equal to 18 years of age.
✓. Subjects must have histologically proven GBM, AA, AMO, malignant astrocytoma NOS or gliosarcoma and recurrent or progressive tumor following prior treatment.
✓. Tumor must be amenable to radical resection, and resection must be clinically indicated.
✓. Must have an ECOG performance status of 0-2.
✓. 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
✕. Abnormal blood tests exceeding any of the limits defined below:
✕. Brainstem, or optic chiasm involvement of tumor.
✕. Uncontrolled seizure disorder.
✕. 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 with radiation therapy, including interstitial radiation or radiosurgery, must be completed at least 8 weeks prior to Day 1.
✕. 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.
✕. Treatment with any investigational drug or approved therapy for investigational use must be completed at least 4 weeks prior to Day 1.
✕. History of intolerance to corticosteroids that would preclude use during this study, or history of any medical condition that precludes the use of corticosteroids.