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Protocol Number:
05-C-0141
- Title:
Phase II Trial of Single Agent Ipilimumab (MDX-010 anti CTLA-4) for Subjects with Locally Advanced or Metastatic Pancreatic Adenocarcinoma
- Number:
05-C-0141
- Summary:
This study will determine whether the experimental drug MDX-010 can cause tumors to shrink in patients with stage IV pancreatic cancer and if it can boost the immune system to fight the cancer. MDX-010 is an antibody to the CTLA-4 protein found on certain lymphocytes (type of white blood cell) that helps stop an immune response. When lymphocytes recognize a foreign substance, such as a virus or bacteria, they initiate an response to fight and control the infection. Once this is achieved, CTLA-4 proteins help stop the immune response, decreasing the number of immune cells against the specific virus or bacteria. When an immune response is mounted against tumor cells, however, it may be beneficial not to stop the immune response, but instead, keep a large number of lymphocytes available to recognize and fight tumor cells. In this study, MDX-010 will be used to block CTLA-4 and maintain immune activity.
Patients 18 years of age and older who have pancreatic cancer that has spread beyond the pancreas and whose tumor cannot be removed surgically may be eligible for this study. Candidates are screened with a history, physical examination, eye examination, blood and urine tests, electrocardiogram, and imaging tests, such as CT or MRI, to evaluate the size and extent of their tumor.
Participants receive four MDX-010 treatments approximately 21 days apart. Each treatment consists of MDX-010 given intravenously (through a vein) over 90 minutes. In addition to the drug treatment, patients have blood tests, a physical examination, and review of symptoms every 21 days (every treatment visit) to look for side effects and the body's reaction to the treatment. They have a final follow-up visit 3 weeks after the fourth treatment for checkup examination, eye examination, scans and x-rays, and blood and urine tests.
Patients are watched closely for treatment side effects. Those who develop severe drug side effects, who develop an immune reaction against the MDX-010 antibody, or whose condition worsens during treatment may be taken off the study. Patients whose tumors remain stable or shrink and who do not develop significant side effects may receive additional courses of treatment.
- Sponsoring Institute:
-
National Cancer Institute (NCI)
- Recruitment Detail
- Type:
Completed Study; data analyses ongoing
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
Children
- Eligibility Criteria:
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Special Instructions:
Currently Not Provided
- Keyword(s):
-
Pancreatic Cancer
-
Anti-CTLA4
-
Immunotherapy
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Metastatic Disease
-
Locally Advanced Disease
- Recruitment Keyword(s):
-
Pancreatic Cancer
- Condition(s):
-
Pancreatic Cancer
- Investigational Drug(s):
-
MDX-010
- Investigational Device(s):
- None
- Interventions:
-
Drug: MDX-010
- Supporting Site:
-
National Cancer Institute
- Contact(s):
-
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Citation(s):
-
Parkin DM, Cancer burden in the year 2000. The global picture. Eur J Cancer. 2001 Oct;37 Suppl 8:S4-66.
-
Jemal A, Cancer statistics, 2003. CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26.
-
White R, Preoperative chemoradiation for patients with locally advanced adenocarcinoma of the pancreas. Ann Surg Oncol. 1999 Jan-Feb;6(1):38-45.
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