AdV-tk + Valacyclovir Therapy in Combination With Surgery and Chemoradiation for Pancreas Cancer
The AdV-tk vector is injected into the tumor or tumor bed at the time of biopsy or standard
tumor surgery after which valacyclovir pills are taken for 14 days. Two courses of AdV-tk,
each followed by valacyclovir, are given as adjuvant to standard of care therapies (surgery
and/or chemoradiation) which have been shown to work cooperatively with AdV-tk to kill tumor
cells. Arm A is for resectable tumors in which the first course is given prior to surgery
and the second is at the time of surgery. Arm B is for locally advanced disease in which
both AdV-tk injections are administered by needle injection into the tumor before and during
chemoradiation. The hypothesis is that this combination therapy can be safely delivered and
will lead to improvement in the clinical outcome for patients with pancreatic cancer.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety based on symptoms and laboratory abnormalities not expected from standard of care treatments or natural history of the disease process. Toxicity grading uses NCI CTC version 3. Dose limiting toxicity is specifically defined in the protocol.
2 months
Yes
Mark Bloomston, MD
Principal Investigator
Ohio State University
United States: Food and Drug Administration
PaTK01
NCT00638612
November 2007
Name | Location |
---|---|
City of Hope Medical Center | Duarte, California 91010 |
The Ohio State University | Columbus, Ohio 43210 |
Scripps Green Hospital/Scripps Cancer Center | La Jolla, California 92037 |