Radiation Therapy, Tadalafil, Sargramostim, Gemcitabine, and Telomerase Vaccine (GV1001) in Patients With Pancreatic Cancer
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.
Locally Advanced Pancreatic Adenocarcinoma
Biological: tadalafil and vaccination
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Exploratory Trial of Immunochemoradiotherapy for Locally Advanced Pancreatic Adenocarcinoma|
- Safety [ Time Frame: 180 Days ] [ Designated as safety issue: Yes ]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.
- Immune Response [ Time Frame: 18 months ] [ Designated as safety issue: No ]In patients having surgery: Tumor tissue obtained at the time of surgery will be examined to determine the degree of macrophage and T cell infiltration. In all patients: Multiparameter flow cytometry will determine the frequency of circulating telomerase-specific memory CD8+ T cells in blood samples obtained pre- and post- treatment. Accrual is anticipate to last 10-12 months, so post treatment samples from the last patient enrolled would be available for analysis approximately 18 months after the first patient enrolled.
- Tumor Response [ Time Frame: 180 days ] [ Designated as safety issue: No ]Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Tumor measurements are made 4 times during the study, the last at 180 days after study enrollment.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||April 2015|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Biological: tadalafil and vaccination
- tadalafil: Cialis
- gemcitabine: Gemzar
- telomerase vaccine: GV1001
- GM-CSF: Sargramostim (Leukine)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342224
|United States, Oregon|
|Providence Health & Services|
|Portland, Oregon, United States, 97213|
|Principal Investigator:||Todd Crocenzi, MD||Providence Health & Services|