UVA Health System seeks men and women 18 to 75 years, with a first or second recurrence of glioblastoma (GBM) or anaplastic astrocytoma (AA) brain cancer following surgery, radiation and temozolomide to participate in a clinical research study. The purpose of this study is to see whether the investigational treatments Toca 511 and Toca FC improve progression-free and overall survival versus standard of care treatment with bevacizumab (Avastin), additional temozolomide, or lomustine (CCNU) in patients receiving surgical resection for their first or second recurrence of GBM or AA.
Toca 511 and Toca FC are investigational agents in this study, meaning they are not yet FDA-approved for the treatment of glioblastoma or anaplastic astrocytoma. Adults who have evidence of regrowth of a GBM or AA tumor after surgery, standard radiation and temozolomide treatment may be eligible to undergo additional screening procedures. Screening of potentially eligible patients who have reviewed the study and agreed to participate includes a clinic visit, questionnaires, MRI, and some blood and urine tests, which must all be completed prior to surgery. Patients who meet all eligibility criteria and are enrolled into the clinical research study will be randomized to receive either Toca 511 and Toca FC study treatments or standard of care treatment, consisting of Avastin, CCNU, or temozolomide. Study participants will have a 50% chance of receiving the study treatments (Toca 511 and Toca FC) and a 50% chance of receiving the standard of care. Toca 511 is applied during surgery and Toca FC is taken by mouth.
Participants will receive their assigned treatment as long as the tumor doesn’t grow significantly and they do not experience unacceptable drug effects. Participants in this study will have routine neurological and physical exams performed every 4-6 weeks as well as tumor evaluations done by MRI. Blood and urine samples will be collected (frequency depends on treatment) for routine, or standard of care, testing. Additional blood will be collected about every 6 weeks for specific research tests required by the study and questionnaires related to quality of life are included. Routine care expenses will be billed to the patient and/or his or her insurance provider. If you are assigned to the group receiving Toca 511 and Toca FC, the study drug will be provided free of charge. Study participants will not receive payment for participating in this study, but may be reimbursed for travel expenses.