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

NCT ID: NCT00112580

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2009-06-30

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.

Conditions

Pancreatic Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ipilimumab

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven A. Rosenberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NCI - Surgery Branch

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, United States

NCI - Surgery Branch

Bethesda, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20842054 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NCI-05-C-0141

Identifier Type: -

Identifier Source: secondary_id

NCI-P6557

Identifier Type: -

Identifier Source: secondary_id

MDX-010-24

Identifier Type: -

Identifier Source: secondary_id

CDR0000430666

Identifier Type: -

Identifier Source: org_study_id

NCT00108888

Identifier Type: -

Identifier Source: nct_alias