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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00112580
First received: June 2, 2005
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Pancreatic Cancer
Biological: ipilimumab
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Clinical response (complete and partial) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of autoimmunity [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: July 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112580

Locations
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
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Principal Investigator: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00112580     History of Changes
Obsolete Identifiers: NCT00108888
Other Study ID Numbers: CDR0000430666, NCI-05-C-0141, NCI-P6557, MDX-010-24
Study First Received: June 2, 2005
Last Updated: April 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 20, 2014