A Phase 1 interventional study of Zoledronic acid in Adenocarcinoma, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-22.
Sponsored by Washington University School of Medicine · Phase 1, Interventional, and Treatment
The overall purpose of this research is to evaluate the safety and side effects of zoledronic acid (also known as Zometa) in patients before they have surgery to remove the cancer.
Cancer of the pancreas carries an ominous prognosis. The five-year overall survival rate of this malignancy is less than 5%. Chemotherapy with gemcitabine carries a response rate of approximately 25%. Resection offers the only potential for cure; however, even with resection, the great majority of patients will die with metastatic disease. Substantial improvements are needed in the treatment of this malignancy.
Patients with this disease process have clearly developed a tolerance to their pancreatic tumor. This is evidenced by an increased number and activity immunosuppressive cells including MDSC and Treg in patients with pancreas cancer. An intervention that inhibits this population of MDSC and Treg may be highly useful in the treatment of this disease process.
A novel treatment of pancreas cancer, in this setting, would be to deplete circulating and tumor-associated immunosuppressive cells prior to resection. This would facilitate the host to mount a greater immune response against the tumor. The eventual goal would be to combine neoadjuvant zoledronic acid with gemcitabine, another agent which synergizes with zoledronic acid to target MDSC. When combined with current adjuvant chemoradiation, the use of zoledronic acid in the neoadjuvant and adjuvant setting, it is hoped that the patient could mount a greater immune response leading to increased overall survival through the prevention of local disease and distant metastasis.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 24 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Exclusion Criteria:
Zoledronic acid 4 mg IV prior to pancreatic resection (approximately 2 weeks prior to resection) Pancreatic resection Zoledronic acid 4 mg IV monthly for two additional doses
Drug: Zoledronic acid
Also known as: Zometa
Evaluate the safety and feasibility perioperative neoadjuvant zoledronic acid in patients with resectable pancreas cancer.
Rate of grade 3 and 4 toxicities, especially nephrotoxicity, electrolyte imbalance and osteonecrosis of the jaw.
Time frame: 1 year postoperatively
Evaluate whether treatment with perioperative zoledronic acid prolongs overall survival or disease free survival.
Time frame: 2 years
Determine the pharmacodynamics on selected immune cell subgroups in the peripheral blood and marrow by flow cytometric analysis.
Time frame: Marrow (prior to first dose of zoledronic acid and week 10), peripheral blood (prior to first dose of zoledronic acid, week 10, and month 6)
Determine the pharmacodynamics of neoadjuvant zoledronic acid therapy on selected immune cell subgroups in the tumor microenvironment by flow cytometric analysis of pancreatic tumor samples.
Time frame: Approximately week 2 (at time of surgery)
Determine the pharmacodynamics of neoadjuvant zoledronic acid therapy on the neoangiogenesis.
Surrogate markers of tumor-associated neoangiogenesis will be analyzed by ELISA. Serum levels of VEGF and MMP9 will be measured compared pre and post treatment.
Time frame: Prior to zoledronic acid treatment and then completion of zoledronic acid treatment (approximately 10 weeks)
Determine the pharmacodynamics and surrogate markers neoangiogenesis analyzed by ELISA.
Serum levels of VEGF and MMP9 will be measured compared pre and post treatment and the expression of VEGF and MMP9 in tumor samples will be analyzed.
Time frame: Prior to zoledronic acid treatment and then completion of zoledronic acid treatment (approximately 10 weeks)
Measure the presence and change of micrometastatic disease present in the bone marrow at the time of surgery versus baseline using immunohistochemistry.
Time frame: Baseline and week 2 (time of surgery)
Evaluate the clinical response and time to disease progression.
Time frame: 6 months postoperatively
Correlate the presence of micrometastatic disease with time to recurrence and outcome.
Time frame: 6 months postoperatively
Measure the change in the amount of micrometastatic disease from baseline.
Time frame: 6 months postoperatively
Determine the pharmacodynamics of neoadjuvant zoledronic acid therapy on selected immune cell subgroups in the hepatic metastatic niche by flow cytometric analysis of pancreatic tumor samples
Time frame: Approximately 2 weeks (time of surgery)
This study is terminated, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine