Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.
Trial Parameters
Brief Summary
The primary goal of this Phase I study is to determine the maximum tolerated dose of oncolytic adenovirus mediated double suicide-gene therapy in combination with fractionated stereotactic radiosurgery in patients with recurrent high-grade astrocytoma undergoing resection.
Eligibility Criteria
Inclusion Criteria: 1. Subjects with radiologic evidence of intracranial recurrence or progression of a previously diagnosed high-grade astrocytoma. To be eligible for this trial, the subjects must have: * Histologically documented glioblastomas or anaplastic astrocytoma prior to the debulking surgery that is suspicious to have progressed on imaging. An interval of at least 3 months must have elapsed since the completion of the most recent course of radiation while at least 4 weeks must have elapsed since the completion of a non-nitrosourea containing chemotherapy regimen and at least 6 weeks since the completion of a nitrosourea containing chemotherapy regimen. * Patients must be ≥ 18 years of age, able to provide informed consent and express a willingness to meet all the expected requirements of the protocol for the duration of the study. * Must have recovered from toxicity (grade 2 or less) of prior therapy. * Eligible for partial or total resection of the recurrent tumor * No antic