A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors
This is an Open label, Phase I, dose escalation study. Patients will receive an injection of
AdV-tk into the tumor or tumor bed during the surgical procedure followed by 14 days of
anti-herpetic prodrug, valacyclovir, starting 1-3 days after vector injection. Standard
radiotherapy will begin 3-7 days after AdV-tK injection. Standard chemotherapy may begin
after completion of valacyclovir at the discretion of the treating physician and family. Two
dose levels of AdV-tk will be evaluated with a fixed dose of valacyclovir.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety based on standard laboratory and clinical adverse event monitoring
2 months
Yes
Mark W Kieran, MD, PhD
Study Chair
Dana-Farber Cancer Institute
United States: Food and Drug Administration
07-098
NCT00634231
April 2010
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Ann & Robert H. Lurie Children's Hospital of Chicago (Formerly Children's Memorial Hospital) | Chicago, Illinois 60611 |