Low Dose Vaccine Study for Surgically Resected Pancreatic Cancer

NCT00614601 | Terminated Phase 2 DMC

• 2 other identifiers: NLG0305OBA#0704-844
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the response for subjects with pancreatic cancer that have undergone surgical resection and treatment with a vaccine given with or without chemotherapy and chemoradiation.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; vaccine therapy

Outcome Measures

Primary Outcomes (1)

• The primary objective of this Phase II trial is to assess disease-free survival (DFS) at one (1) year following initiation of treatment as the primary endpoint of the study in subjects treated with the HyperAcute®-Pancreatic Cancer Vaccine

  One year

Secondary Outcomes (1)

• We will use overall survival and adverse events rates as secondary endpoints.

  Duration of study

Study Arms (2)

1

EXPERIMENTAL

Vaccine + chemo + chemoradiation therapy

Biological: HyperAcute(R)-Pancreatic Cancer Vaccine

2

EXPERIMENTAL

Vaccine Only

Biological: HyperAcute(R)-Pancreatic Cancer Vaccine

Interventions

HyperAcute(R)-Pancreatic Cancer Vaccine BIOLOGICAL

100 million vaccine cells will be injected intradermally for up to 14 vaccinations over approximately 8 months

Also known as: HAPa-1 and HAPa-2 vaccine components

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A histological diagnosis of adenocarcinoma of the pancreas. The patient's pathology must be reviewed and confirmed by the clinical site's Pathology Department.
• 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 or 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 have a negative serology for HIV prior to entering study.
• Subjects must be able to take in ≥ 1500 calories daily.
• Adequate organ function including:
• Marrow: WBC ≥3000/mm3 and platelets ≥100,000/mm3.
• Hepatic: serum total bilirubin ≤ 2 x ULN mg/dL, ALT (SGPT) and AST (SGOT) ≤3 x upper limit of normal (ULN).
• Renal: serum creatinine (sCr) ≤2.0 x ULN, or creatinine clearance (Ccr) ≥30 mL/min.
• First vaccination must be within 6 weeks after surgery.
• Patients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able give written informed consent to participate.
• 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.

You may not qualify if:

• Age \<18-years-old.
• Active metastases.
• Other malignancy within five years, unless the probability of recurrence of the prior malignancy is \<5%. 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 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 1-week 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 vaccine or cell lines.
• 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 7 days of first vaccination).

Sponsors & Collaborators

• NewLink Genetics Corporation: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40292, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Charles J. Link, M.D.

  NewLink Genetics Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: December 1, 2014
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

US (1)