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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00892242 |
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.
Condition | Intervention | Phase |
---|---|---|
Adenocarcinoma |
Drug: zoledronic acid |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Study of Single Dose Neoadjuvant Zoledronic Acid in Patients With Resectable Pancreas Cancer |
Estimated Enrollment: | 48 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: zoledronic acid
Cohort 1: zoledronic acid 4.0 mg
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2: Experimental |
Drug: zoledronic acid
Cohort 2: zoledronic acid 8.0 mg
|
3: Experimental |
Drug: zoledronic acid
Cohort 3: zoledronic acid 12.0 mg
|
4: Experimental |
Drug: zoledronic acid
Cohort 4: zoledronic acid 16.0 mg
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A patient will be eligible for inclusion in this study only if ALL of the following criteria apply;
Exclusion Criteria:
A patient will be ineligible for inclusion into this study if ANY of the following criteria apply:
Contact: David Linehan, M.D. | 314-362-2938 | linehand@wudosis.wustl.edu |
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | David Linehan, M.D. | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( David Linehan, M.D. ) |
Study ID Numbers: | 08-X263 |
Study First Received: | May 1, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00892242 History of Changes |
Health Authority: | United States: Institutional Review Board |
Neoadjuvant zoledronic acid in resectable pancreas cancer |
Digestive System Neoplasms Zoledronic acid Pancreatic Neoplasms Endocrine System Diseases Bone Density Conservation Agents Pancrelipase Carcinoma Diphosphonates |
Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Zoledronic acid Neoplasms by Histologic Type Digestive System Neoplasms Pancreatic Neoplasms Physiological Effects of Drugs Gastrointestinal Agents Endocrine System Diseases Bone Density Conservation Agents Pancrelipase Pharmacologic Actions |
Carcinoma Neoplasms Diphosphonates Neoplasms by Site Digestive System Diseases Therapeutic Uses Pancreatic Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |