THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on pancreatic cancer. These studies are investigating radiotherapy; cancer vaccines; combination treatments; novel cell therapies; response prediction; and more. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
PHASE I
Study Title: A Dose-Escalation Trial of Stereotactic Body Radiotherapy (SBRT) After Induction Chemotherapy for Locally Advanced Pancreatic Cancer
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: University of Colorado, Denver
Purpose: To evaluate the safety of SBRT delivered in three fractions for patients with locally advanced pancreatic cancer who have received induction chemotherapy (FOLFIRINOX [leucovorin, fluorouracil, irinotecan, oxaliplatin] or gemcitabine and nab-paclitaxel [Abraxane])
Primary Outcome Measures: The maximum tolerated dose of SBRT in patients with locally advanced pancreatic cancer who have not developed distant disease progression after induction chemotherapies per standard of care [time frame: up to 3 months]
Principal Investigator: Karyn C. Goodman, MD, University of Colorado, Denver; contact Robyn Swing, (720) 848-0607, robyn. swing@ucdenver.edu
ClinicalTrials.gov Identifier: NCT02873598
PHASE I/II
Study Title: A Randomized Study of a GM-CSF–Secreting Allogeneic Pancreatic Cancer Vaccine With or Without a PD-1 Blockade Antibody (Nivolumab) for the Neoadjuvant and Adjuvant Treatment of Patients With Surgically Resectable Adenocarcinoma of the Pancreas
Study Type: Interventional/randomized/parallel assignment
Study Sponsor and Collaborators: Sidney Kimmel Comprehensive Cancer Center
Purpose: To study whether cyclophosphamide plus an immune system–activating pancreatic cancer vaccine (known as GVAX) with nivolumab [Opdivo] is more effective than cyclophosphamide/GVAX alone in altering the pancreatic tumor microenvironment (interleukin 17 expression) to aid in antitumor response
Primary Outcome Measures: Median IL-17A expression in vaccine-induced lymphoid aggregates found in surgically resected pancreatic tumors [time frame: 4 years]
Principal Investigator: Lei Zheng, MD, PhD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University; contact Carol Judkins, RN, (410) 614-5241, judkica@jhmi.edu
ClinicalTrials.gov Identifier: NCT02451982
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Study Title: Tumor-Associated Antigen (TAA)-Specific Cytotoxic T Lymphocytes Administered in Patients With Pancreatic Cancer
Study Type: Interventional/nonrandomized/parallel assignment
Study Sponsor and Collaborators: Baylor College of Medicine; Center for Cell and Gene Therapy, Baylor College of Medicine; The Methodist Hospital System; Pancreatic Cancer Action Network; The V Foundation for Cancer Research; Harris County Hospital District
Purpose: To study the activity of five kinds of immune system cells called TAA-specific cytotoxic T lymphocytes (NY-ESO-1, MAGEA4, PRAME, survivin, and SSX2) in pancreatic cancer
Primary Outcome Measures: Number of patients with treatment-related serious adverse events [time frame: 7 months], number of patients who received six infusions of multiTAA-specific T cells [time frame: 6 months]
Principal Investigators: Yvonne Sada, MD; Anne Leen, PhD; Brandon Smaglo, MD; Baylor College of Medicine. Contact Dr. Smaglo, (713) 798-3342, smaglo@bcm.edu
ClinicalTrials.gov Identifier: NCT03192462
PHASE II
Study Title: BrUOG 292: FOLFOX-A for Metastatic Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Brown University, Lifespan, SouthCoast Medical Group, Memorial Hospital
Purpose: To study the activity and side effects of FOLFOX-A (fluorouracil, oxaliplatin, leucovorin, and protein-bound paclitaxel) vs FOLFIRINOX in metastatic pancreatic cancer
Primary Outcome Measures: Survival for patients with metastatic pancreatic cancer with first-line treatment with FOLFOX-A as compared with historical controls of gemcitabine alone [time frame: every 3 months for up to 5 years]
Principal Investigator: Howard Safran, MD, Lifespan; (401) 863-3000
ClinicalTrials.gov Identifier: NCT02080221
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Study Title: Circulating Tumor Cell and Tumor Tissue Models for Predicting Effective Pancreatic Cancer Response
Study Type: Observational/cohort
Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center
Purpose: To develop a test to predict response of pancreatic cancer to different chemotherapy regimens
Primary Outcome Measures: Progression-free survival [time frame: 36 months]
Principal Investigator: Kenneth Yu, MD, Memorial Sloan Kettering Cancer Center; (646) 888-4188, yuk1@mskcc.org
ClinicalTrials.gov Identifier: NCT03033927
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Study Title: Efficacy of Doxycycline on Metakaryote Cell Death in Patients With Resectable Pancreatic Cancer
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Medical College of Wisconsin
Purpose: To study the efficacy of doxycycline, an oral antibiotic, on metakaryotic (cancer stem cells) in resectable pancreatic cancer following 8 weeks of treatment
Primary Outcome Measures: Efficacy of doxycycline in inducing metakaryotic cell death in primary pancreatic tumors as measured by pathologic response [time frame: 3 months]
Principal Investigator: Susan Tsai, MD, MHS, Medical College of Wisconsin; contact Medical College of Wisconsin Cancer Center, (414) 805-8900, cccto@mcw.edu
ClinicalTrials.gov Identifier: NCT02775695
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov. ■
