Glioblastoma Multiforme Clinical Trial
Official title:
A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511
This is a multicenter, open-label, continuation study to allow subjects who have previously
received Toca 511 to continue to receive Toca FC and to allow for extended safety
observations. Subjects will be seen on an every six week basis for 1 year or longer. Subjects
who continue to receive Toca FC will receive the dose described in the "parent" protocol. If
the Toca FC dose is adjusted for any reason, the serum concentration will be monitored.
Gadolinium (Gd)-enhanced magnetic resonance imaging (MRI) scans will be performed as per
standard of care.
If the subject has recurred/progressed, repeat intracranial injection of Toca 511 followed by
Toca FC treatment may be offered to consenting patients.
Subjects who enter the study to continue Toca FC and subsequently discontinue Toca FC, and
subjects who are only willing or able to perform limited testing will have viral testing
alone, at the appropriate intervals.
After the first year, subjects will be seen twice yearly for the next 4 years and then
contacted yearly for the next 10 years.
All subjects will be followed on study for at least 5 years regardless of whether they are
taking Toca FC.
n/a
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