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MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ipilimumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
  • NCI - Surgery Branch

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)
Percentage of participants who achieved Complete Response (CR) or Partial Response (PR) according to RECIST criteria. Particularly, CR is defined as disappearance of all target lesions, while PR is defined as at least a 30% decrease n the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2005
Last Updated
September 24, 2021
Sponsor
Bristol-Myers Squibb
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00112580
Brief Title
MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery
Official Title
Phase II Trial of Single Agent Ipilimumab (MDX-010 Anti CTLA-4) for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 31, 2005 (Actual)
Primary Completion Date
June 30, 2009 (Actual)
Study Completion Date
June 30, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
ipilimumab
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)
Description
Percentage of participants who achieved Complete Response (CR) or Partial Response (PR) according to RECIST criteria. Particularly, CR is defined as disappearance of all target lesions, while PR is defined as at least a 30% decrease n the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Time Frame
From first dose to 3 weeks following the end of the treatment cycle, up to 24 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A. Rosenberg, MD, PhD
Organizational Affiliation
NCI - Surgery Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
NCI - Surgery Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20842054
Citation
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.
Results Reference
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MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery

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