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

Pancreatic Cancer Clinical Trial

Official title:

Phase II Trial of Single Agent Ipilimumab (MDX-010 Anti CTLA-4) for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112580
• Other study ID #: CDR0000430666
• Secondary ID: NCI-05-C-0141NCI
• Status: Completed
• Phase: Phase 2
• Start date: July 31, 2005
• Est. completion date: June 30, 2009

Study information

• Verified date: September 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00108888

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 30, 2009
• Est. primary completion date: June 30, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• ipilimumab

Locations

Country	Name	City	State
United States	NCI - Surgery Branch	Bethesda	Maryland
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first dose to 3 weeks following the end of the treatment cycle, up to 24 weeks.