MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Single Agent Ipilimumab (MDX-010 Anti CTLA-4) for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma|
- Clinical response (complete and partial) [ Designated as safety issue: No ]
- Incidence of autoimmunity [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
- 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.
|United States, Maryland|
|NCI - Surgery Branch|
|Bethesda, Maryland, United States, 20892|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|Principal Investigator:||Steven A. Rosenberg, MD, PhD||NCI - Surgery Branch|