NCT01342224

Immunochemoradiotherapy in Patients With Pancreatic Cancer

Exploratory Trial of Immunochemoradiotherapy for Locally Advanced Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Locally Advanced Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
BIOLOGICAL	tadalafil and vaccination	Participants receive a 4-week course of vaccination with telomerase vaccine and GM-CSF by injection, along with a cycle of gemcitabine chemotherapy (IV). This is followed by radiation and gemcitabine given twice weekly then by another dose of vaccine. Four weeks after completion of chemotherapy and radiation, participants able to have surgical treatment will have surgery followed by vaccination and chemotherapy. Participants with stable or responsive disease that cannot be treated by surgery will have vaccination and chemotherapy with 2 cycles of telomerase vaccine with GM-CSF along with gemcitabine. Participants with unresectable and progressive disease after administration of vaccine, chemotherapy and radiation treatment may transition to vaccination and chemotherapy treatment.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-06-01
• Completion: 2018-04-01
• First posted: 2011-04-27
• Last updated: 2018-04-12

Locations

1 site across 1 country: United States