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Complete title: A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without HyperAcute ® Pancreas (Algenpantucel-L) Immunotherapy in Subjects with Surgically Resected Pancreatic Cancer
|Research Study Number||7259|
|Principal Investigator||Andrew Coveler, MD|
Research Study Description
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.
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- A histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology. Mixed subtypes of adenocarcinoma are acceptable as long as majority of cells are ductal adenocarcinoma.
- 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 8 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.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Active metastases. Suspicious lesions on CT scans must be reviewed by a second, different reviewer. If active disease not ruled out by second reviewer, 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 eligible.
- 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 ßHCG must be completed within 7 days of first vaccination).
- Known HIV positive.
Other exclusion criteria may apply.
Gastrointestinal Cancer; Pancreatic Cancer; Solid Tumors
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