Phase II Trial of Single Agent Ipilimumab (MDX-010 Anti CTLA-4) for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
18 Years
N/A
Both
Pancreatic Cancer
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 Office | Bethesda, Maryland 20892-1182 |
| NCI - Surgery Branch | Bethesda, Maryland 20892-1201 |
