Locally Advanced Pancreatic Adenocarcinoma Clinical Trial
Official title:
Exploratory Trial of Immunochemoradiotherapy for Locally Advanced Pancreatic Adenocarcinoma
This study will add an immunotherapy component to chemotherapy and radiation treatment in patients who have pancreatic cancer. The objective of this study is to see if the combined treatment is safe and feasible, and if a larger study is warranted.
All study participants receive an initial 4 week course of intra-dermal vaccination with
telomerase vaccine (GV1001) and immune adjuvant, granulocyte macrophage colony-stimulating
factor (GM-CSF), along with a cycle of gemcitabine chemotherapy. This is followed by
concurrent radiation therapy and low-dose intravenous (IV) gemcitabine chemotherapy given
twice weekly followed by one additional dose of vaccine.
About 4 weeks (as late as 8 weeks) after chemotherapy and radiation treatment, participants
with disease that can be removed by surgery will proceed to surgery. After recovery,
immunochemotherapy will resume.
Participants with stable or responsive disease that is not able to be treated with surgery
will proceed to immunochemotherapy.
Immunochemotherapy will consist of 2 cycles of telomerase vaccine with GM-CSF along with
gemcitabine chemotherapy. Participants with disease that is not able to be treated with
surgery, or that has worsened following immunochemoradiotherapy phase of treatment may
continue on study with transition to immunochemotherapy phase of treatment. Tadalafil will be
administered orally on a daily basis from start of therapy (Day 1) through completion of
therapy with doses held only when required in the immediate perioperative period in patients
who proceed to surgery.
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