Immunotherapy Study for Surgically Resected Pancreatic Cancer

Not Recruiting

Trial ID: NCT01072981


The purpose of this study is to assess overall survival after treatment with a regimen of adjuvant therapy (Gemcitabine alone or with 5-FU chemoradiation) with or without HyperAcute®-Pancreas (algenpantucel-L) immunotherapy in subjects who have undergone surgical resection.

Official Title

A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without Algenpantucel-L (HyperAcute®-Pancreas) Immunotherapy in Subjects With Surgically Resected Pancreatic Cancer

Stanford Investigator(s)

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine


Inclusion Criteria:

   - A histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology.

   - American Joint Committee on Cancer (AJCC) Stage I or II Pancreatic carcinoma. Patients
   must have undergone surgical resection for the tumor and extent of resection must be
   either R0 (complete resection with grossly and microscopically negative margins of
   resection) or R1 (grossly negative but positive microscopically margins of resection).

   - Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.

   - Serum albumin ≥2.0 gm/dL.

   - Expected survival ≥6 months.

   - Subjects must be able to take in adequate daily calorie intake based on judgment of
   clinical investigator.

   - Adequate organ function including:

   - A. Marrow: white blood cells (WBC) ≥3000/mm3 and platelets ≥100,000/mm3.

   - B. Hepatic: serum total bilirubin ≤2 x ULN mg/dL, ALT (SGPT) and AST (SGOT) ≤3 x upper
   limit of normal (ULN).

   - C. Renal: serum creatinine (sCr) ≤2.0 x ULN, or creatinine clearance (Ccr) ≥30 mL/min.

   - First vaccination must be within 10 weeks after surgery.

   - Patients must have the ability to understand the study, its inherent risks, side
   effects and potential benefits and be able to give written informed consent to
   participate. Patients may not be consented by a durable power of attorney (DPA).

   - All subjects of child producing potential must agree to use contraception or avoidance
   of pregnancy measures while enrolled on study and receiving the experimental product,
   and for one month after the last immunization.

Exclusion Criteria:

   - Age <18-years-old.

   - Active metastases. Suspicious lesions on CT scans must be reviewed by a second,
   different reviewer. If active disease not ruled out by second, different reviewer (at
   clinical institution), a positron emission tomography (PET) CT or further imaging
   tests or histology may be needed to rule out disease before enrollment is allowed.

   - Other malignancy within five years, unless the probability of recurrence of the prior
   malignancy is <5% as determined by the Principal Investigator based on available
   information. Patient's curatively treated for squamous and basal cell carcinoma of the
   skin or patients with a history of malignant tumor in the past that have been disease
   free for at least five years are also eligible for this study.

   - History of organ transplant.

   - Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.

   - Subjects taking chronic systemic corticosteroid therapy for any reason are not
   eligible. Subjects may receive steroids as prophylactic anti-emetics, not to exceed 10
   mg Decadron weekly. Subjects may also receive pulse doses for Gemcitabine
   hypersensitivity, not to exceed Decadron 8 mg twice a day (BID) x 3 days prior to
   start day of Gemcitabine. Subjects receiving inhaled or topical corticosteroids are
   eligible. Subjects who require chronic systemic corticosteroids after beginning
   vaccination, will be removed from study.

   - Significant or uncontrolled congestive heart failure (CHF),myocardial infarction or
   significant ventricular arrhythmias within the last six months.

   - Active infection or antibiotics within 48 hours prior to study,including unexplained
   fever (temp > 38.1C).

   - Autoimmune disease (e.g., systemic lupus erythematosis (SLE), rheumatoid arthritis
   (RA), etc.). Patients with a remote history of asthma or mild active asthma are

   - Other serious medical conditions that may be expected to limit life expectancy to less
   than 2 years (e.g., liver cirrhosis) or a serious illness in medical opinion of the
   clinical investigator.

   - Any condition, psychiatric or otherwise, that would preclude informed consent,
   consistent follow-up or compliance with any aspect of the study (e.g., untreated
   schizophrenia or other significant cognitive impairment, etc.).

   - A known allergy to any component of the HyperAcute® immunotherapy.

   - Pregnant or nursing women due to the unknown effects of vaccination on the developing
   fetus or newborn infant. (For patients with child bearing potential, a βHCG must be
   completed within 14 days of first vaccination).

   - Known HIV positive.


biological: HyperAcute-Pancreas Immunotherapy

drug: Gemcitabine

radiation: 5FU Chemoradiation

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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