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A Feasibility and Safety Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells in Patients With Metastatic, Locally Advanced, Unresectable, or Recurrent Pancreatic Adenocarcinoma

Phase 1
18 Years
Open (Enrolling)
Metastatic Pancreatic Cancer

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Trial Information

A Feasibility and Safety Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells in Patients With Metastatic, Locally Advanced, Unresectable, or Recurrent Pancreatic Adenocarcinoma

Primary Objectives

1. Assess the safety of this treatment by evaluating the qualitative and quantitative
toxicities in this group of patients.

2. Determine the feasibility of generating dendritic cells and administering these cells
as a vaccine to patients.

Secondary Objectives

1. Assess anti-tumor activity after vaccination, measured by change in tumor burden and
overall survival.

2. Assess immunological responses after vaccination (antigen-specific T cell cytokine
production, antigen-specific T cell frequencies by tetramer analysis, and DTH

Inclusion Criteria

Eligibility Criteria:

- Patients must have histologically or cytologically confirmed diagnosis of pancreatic
adenocarcinoma that is metastatic, locally advanced, unresectable, or recurrent.
Patients with endocrine or neuroendocrine tumors, lymphoma of the pancreas, or
ampullary cancer are not eligible. If the histologic diagnosis is based on a
metastatic site, the histology must be compatible with pancreatic cancer.

- Patient must not have clinically significant ascites.

- Patients must be HLA-A2 positivity by serological testing.

- Prior surgery is allowed provided at least 14 days has elapsed between surgery and
registration. Prior radiation/chemo is allowed provided that at least 28 days have
elapsed since the last treatment.

- One or more tumors measurable on CT scan per RECIST 1.1. (Eisenhauer)

- Eastern Cooperative Oncology Group (ECOG) performance status < 2.

- Age > 18 years.

- Patient must have an expected life expectancy greater than 3 months.

- Signed, written IRB-approved informed consent.

- A negative pregnancy test (if female).

- Acceptable organ function:

- Bilirubin < 3 times upper limit of normal (CTCAE Grade 2 baseline)

- AST (SGOT), ALT (SGPT) < 3 x ULN (CTCAE Grade 1 baseline)

- Serum creatinine < 1.5 XULN (CTCAE Grade 1 baseline)

- Acceptable hematologic status:

- Absolute neutrophil count > 1000 cells/mm3,

- Platelet count > 75,000 (plt/mm3), (CTCAE Grade 1 baseline)

- Hemoglobin > 9 g/dL.

- Urinalysis: No clinically significant abnormalities.

- PT and PTT < 1.5 X ULN after correction of nutritional deficiencies that may
contribute to prolonged PT/PTT.

- No evidence of clinically significant, uncontrolled cardiovascular, endocrine, or
infectious disease.

Exclusion Criteria

- Patients must not have any serious uncontrolled acute or chronic medical condition
that would interfere with this treatment. An example would be an active acute or
chronic infection requiring antibiotics

- Patients must not have significant ongoing cardiac problems, myocardial infarction
within the last six months, uncontrolled hypertension, unstable angina, uncontrolled
arrhythmia or congestive heart failure.

- Patients with known brain metastases are not eligible. However, brain-imaging
studies are not required for eligibility if the patient has no neurologic signs or
symptoms. If brain-imaging studies are performed, they must be negative for disease.

- Patients must have no plans to receive concurrent chemotherapy, hormonal therapy,
radiotherapy, immunotherapy or any other type of therapy for treatment of cancer
while on this protocol treatment.

- Due to the undetermined effect of this treatment regimen in patients with HIV-1
infection and the potential for serious interaction with anti-HIV medications,
patients known to be infected with HIV are not eligible for this study.

- Due to the possibility of harm to a fetus or nursing infant from this treatment
regimen, patients must not be pregnant or nursing. Women and men of reproductive
potential must have agreed to use an effective contraceptive method.

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
Stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease free for five years.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Any protocol deviations will be described and the protocol schedule will be re-assessed to improve feasibility of implementation if necessary. The proportion of patients successfully completing the protocol (i.e., without deviations) will be reported with a one-sided 90% confidence interval. If the observed feasibility rate is >0.80, the lower limit will be no lower than 0.60.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Steve H. Chin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Medical University of South Carolina Charleston, South Carolina  29425-0721