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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

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)

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response (complete and partial)

Safety Issue:

No

Principal Investigator

Steven A. Rosenberg, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000430666

NCT ID:

NCT00112580

Start Date:

July 2005

Completion Date:

June 2009

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182
NCI - Surgery BranchBethesda, Maryland  20892-1201