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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE June 2, 2005
First Posted Date  ICMJE June 3, 2005
Last Update Posted Date October 12, 2015
Study Start Date  ICMJE July 2005
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2007)
Clinical response (complete and partial)
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2007)
Incidence of autoimmunity
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery
Official Title  ICMJE Phase II Trial of Single Agent Ipilimumab (MDX-010 Anti CTLA-4) for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

  • 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).

Secondary

  • 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Biological: ipilimumab
Study Arms  ICMJE Not Provided
Publications * Royal RE, Levy C, Turner K, Mathur A, Hughes M, Kammula US, Sherry RM, Topalian SL, Yang JC, Lowy I, Rosenberg SA. Phase 2 trial of single agent Ipilimumab (anti-CTLA-4) for locally advanced or metastatic pancreatic adenocarcinoma. J Immunother. 2010 Oct;33(8):828-33. doi: 10.1097/CJI.0b013e3181eec14c.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
82
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed pancreatic adenocarcinoma

    • Stage IV disease

      • Locally (invasion of adjacent structures, including mesenteric arteries or organs) or distantly metastatic disease
    • Unresectable disease
    • Pancreatic adenocarcinoma with intraductal papillary mucinous neoplasm allowed
  • The following diagnoses are not allowed:

    • Acinar cell carcinoma
    • Pancreaticoblastoma
    • Malignant cystic neoplasms
    • Endocrine neoplasms
    • Squamous cell carcinoma
    • Vater and periampullary duodenal or common bile duct malignancies
  • Clinically evaluable disease with ≥ 1 site of measurable disease
  • Biliary or gastric outlet obstruction allowed provided it is effectively drained by endoscopic, operative, or interventional means
  • Pancreatic, biliary, or enteric fistulae allowed provided they are controlled with an appropriate drain

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • WBC ≥ 2,500/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • Hematocrit ≥ 27%

Hepatic

  • Hepatitis B surface antigen negative
  • Hepatitis C virus antibody negative OR
  • Hepatitis C RNA negative by polymerase chain reaction

Renal

  • Creatinine < 2.0 mg/dL

Immunologic

  • HIV negative
  • No history of or active autoimmune disease, including uveitis or autoimmune inflammatory eye disease
  • No active uncontrolled infection

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
  • No underlying medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010)

Chemotherapy

  • At least 3 weeks since prior chemotherapy for pancreatic adenocarcinoma and recovered
  • No concurrent chemotherapy

Endocrine therapy

  • More than 4 weeks since prior corticosteroids
  • No concurrent systemic or topical corticosteroids

Radiotherapy

  • At least 3 weeks since prior radiotherapy for pancreatic adenocarcinoma and recovered

Surgery

  • See Disease Characteristics

Other

  • At least 3 weeks since other prior therapy for pancreatic adenocarcinoma and recovered
  • No concurrent immunosuppressants (e.g., cyclosporin or its analog)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00112580
Other Study ID Numbers  ICMJE CDR0000430666
NCI-05-C-0141
NCI-P6557
MDX-010-24
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
PRS Account Bristol-Myers Squibb
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP