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Immunotherapy Study for Surgically Resected Pancreatic Cancer
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.
A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without Algenpantucel-L (HyperAcute®-Pancreas) Immunotherapy in Subjects With Surgically Resected Pancreatic Cancer
- 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
- 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.
- 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
- 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
radiation: 5FU Chemoradiation
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office