G207 Followed by Radiation Therapy in Malignant Glioma
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
This is an open-label, single site study to evaluate the safety and tolerability of
intratumoral administration of G207 followed by treatment with radiation therapy in patients
with recurrent/progressive malignant glioma.
This study is a two stage phase 1 study, in which a de-escalating dosing scheme will be used,
i.e. the first patients will receive the higher dose and if excessive toxicity occurs, the
dose will be reduced for the following patients. The purpose of the dose de-escalation phase
is to find the best safe dose of G207.
In the first stage of the study, treatment with G207 will be followed by focal radiation
therapy on the following day, and in the second stage treatment with G207 will be followed by
gamma knife surgery also on the following day.
All patients will return to the clinic 28 days and 3, 6, 9 and 12 months after G207
administration at which time clinical assessments will be performed, and will be followed for
safety and survival at clinic visits or by telephone every 3 months for up to 2 additional
years and annually thereafter.