MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00112580|
Recruitment Status : Completed
First Posted : June 3, 2005
Last Update Posted : October 12, 2015
RATIONALE: Biological therapies, such as MDX-010, may stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase II trial is studying how well MDX-010 works in treating patients with stage IV pancreatic cancer that cannot be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Biological: ipilimumab||Phase 2|
- Determine clinical response (partial and complete responses) in patients with unresectable stage IV (locally or distantly metastatic) pancreatic adenocarcinoma treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010).
- Determine whether observed responses correlate with the incidence of autoimmunity in patients treated with this drug.
OUTLINE: This is an open-label study. Patients are stratified according to status of disease (locally vs distantly metastatic).
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on days 0, 21, 42, and 63. Treatment repeats every 84 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression after achieving a partial response or complete response receive 2 additional courses of therapy.
After completion of study treatment, patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 42-82 patients (21-41 per stratum) will be accrued for this study within 2-4 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Single Agent Ipilimumab (MDX-010 Anti CTLA-4) for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
- Clinical response (complete and partial)
- Incidence of autoimmunity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112580
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|NCI - Surgery Branch|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Steven A. Rosenberg, MD, PhD||NCI - Surgery Branch|