Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NCI-05-C-0141 NCI-P6557, MDX-010-24, NCT00112580

Special Category: NCI Web site featured trial

Objectives

Primary

1. 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

1. Determine whether observed responses correlate with the incidence of autoimmunity in patients treated with this drug.

Entry 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

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)

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• WBC ≥ 2,500/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

A total of 42-82 patients (21-41 per stratum) will be accrued for this study within 2-4 years.

Outcomes

Clinical response (complete and partial)

Incidence of autoimmunity

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Steven Rosenberg, MD, PhD, Principal investigator		Ph: 301-496-4164 Email: sar@nih.gov

Related Information

Featured trial article

Registry Information
Official Title		Phase II Trial of Single Agent Ipilimumab (MDX-010 anti CTLA-4) for Subjects with Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Trial Start Date		2005-07-18
Trial Completion Date		2009-08-07
Registered in ClinicalTrials.gov		NCT00112580
Date Submitted to PDQ		2005-04-25
Information Last Verified		2009-08-26

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