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Immunotherapy Study for Surgically Resected Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01072981
Recruitment Status : Completed
First Posted : February 22, 2010
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Lumos Pharma ( NewLink Genetics Corporation )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: HyperAcute-Pancreas Immunotherapy Drug: Gemcitabine Radiation: 5FU Chemoradiation Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 722 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2010
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: HyperAcute-Pancreas Immunotherapy + Standard of Care
*Adjuvant Standard of Care Treatment (SOC) consisting of gemcitabine with or without 5FU chemoradiation + HyperAcute Immunotherapy
 Biological: HyperAcute-Pancreas Immunotherapy
Up to 18 immunizations of 300 million immunotherapy cells
Other Name: HAPa-1 and HAPa-2 immunotherapy components

Drug: Gemcitabine
Gemcitabine 1000 mg/m2/day once a week for 3 weeks
Other Name: Gemzar

Radiation: 5FU Chemoradiation
5FU 200-250 mg/m2/day over 5 1/2 weeks with radiation.
Other Name: Fluorouracil
Active Comparator: Standard of Care alone
*Adjuvant Standard of Care Treatment (SOC) consisting of gemcitabine with or without 5FU chemoradiation Alone
 Drug: Gemcitabine
Gemcitabine 1000 mg/m2/day once a week for 3 weeks
Other Name: Gemzar

Radiation: 5FU Chemoradiation
5FU 200-250 mg/m2/day over 5 1/2 weeks with radiation.
Other Name: Fluorouracil


Outcome Measures
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Primary Outcome Measures :
  1. The primary objective is to assess overall survival [ Time Frame: Approximately 41 months and 48 months ]

Secondary Outcome Measures :
  1. The secondary objective is to assess disease free survival and to conduct correlative scientific studies of subject samples to determine the mechanism of any observed anti-tumor effect. [ Time Frame: Approximately 41 months and 48 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 βHCG must be completed within 14 days of first vaccination).
  • Known HIV positive.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072981


Locations
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Sponsors and Collaborators
NewLink Genetics Corporation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NewLink Genetics Corporation
ClinicalTrials.gov Identifier: NCT01072981    
Other Study ID Numbers: NLG0405
OBA# 0912-1013 ( Other Identifier: Office of Biotechnology Activities )
First Posted: February 22, 2010    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Keywords provided by Lumos Pharma ( NewLink Genetics Corporation ):
Pancreatic Cancer
Vaccine Therapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Fluorouracil
Pancrelipase
 Immunologic Factors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Physiological Effects of Drugs
Gastrointestinal Agents