Exploratory Trial of Immunochemoradiotherapy for Locally Advanced Pancreatic Adenocarcinoma
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Adverse events will be graded no less than weekly for the first 180 days. Post-treatment long-term follow-up will occur every 12 weeks beyond day 180 for 6 visits and then every 24 weeks thereafter until progressive disease, withdrawal from study or death. For this pilot study, adverse events and efficacy measures will be personally reviewed by the principal investigator. Both hematologic and non-hematologic toxicity will be anticipated. In conjunction with the IRB, stopping the trial will be among possible measures taken if undue toxicity or inadequate outcomes are observed.
Todd Crocenzi, MD
Providence Health & Services
United States: Food and Drug Administration
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