Study on Boosting GVAX Pancreas Vaccine with or without Cyclophosphamide for Pancreatic Cancer Patients

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60

ClinicalTrials ID:NCT01088789

Provider View

This clinical trial is testing the safety and feasibility of a pancreatic cancer vaccine, GVAX, either alone or combined with cyclophosphamide, in patients who have had surgery for pancreatic cancer.

Patient Parameters

Program Overview

The study aims to evaluate the safety and practicality of using a vaccine called GVAX Pancreas Vaccine, which is made from pancreatic tumor cells and a gene that stimulates the immune system. The vaccine is tested alone or with a drug called cyclophosphamide, given either as a single dose or in small daily doses. This treatment is for patients who have had surgery to remove pancreatic cancer.

Eligibility Criteria

Inclusion Criteria

  • Have had surgery to remove stage I or II pancreatic cancer from the head, neck, or uncinate of the pancreas.
  • For certain groups, must have participated in specific previous studies at Johns Hopkins.
  • For one group, must not have received any pancreatic cancer vaccine or immunotherapy before, had surgery within the last 18 months, and completed chemotherapy or chemoradiation.
  • For certain groups, must have received a specific type of pancreatic cell vaccine 6-12 months ago.
  • Must have finished the last cancer treatment at least 28 days ago.
  • Must be in good general health with an ECOG performance status of 0 or 1.
  • Must agree to participate and provide informed consent.
  • Must have adequate blood cell counts and organ function, including:
    • Hemoglobin level of at least 9 g/dL.
    • Neutrophil count of at least 1500/mm3.
    • Platelet count of at least 100,000/mm3.
    • Kidney function with serum creatinine of 2 mg/dL or less.
    • Liver function with bilirubin of 2.0 mg/dL or less, unless known Gilbert's Syndrome, and liver enzymes within specified limits.
  • Must agree to use effective birth control if capable of having children.

Exclusion Criteria

  • Have signs of pancreatic cancer returning.
  • Have a history of autoimmune diseases like lupus, rheumatoid arthritis, or vasculitis.
  • Have any uncontrolled medical conditions.
  • Have used systemic steroids within 28 days before receiving the vaccine.
  • Expect to need systemic steroids within 28 days after receiving the vaccine.
  • Have any active infections.
  • Are pregnant.
  • Have had another type of cancer or blood disorders in the past five years, except for certain treated skin cancers or cervical cancer.
  • Have a history of not following treatment or monitoring instructions in previous vaccine cycles.

Locations

FACILITYZIPCITYSTATE
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins21205BaltimoreMaryland

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