Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer

A Safety and Efficacy Trial of Vaccine Boosting With Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene for the Treatment of Pancreatic Adenocarcinoma

This is an open label, phase II trial study of adjuvant GVAX pancreas vaccine in patients with pancreatic cancer.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Biological: GVAX pancreas vaccine

Detailed Description

Eligible participants will receive by intradermal administration the GVAX pancreas vaccine consisting of two irradiated allogeneic pancreatic tumor cell lines transfected with the granulocyte macrophage-colony stimulating factor (GM-CSF) gene.

There will be two cohorts of research participants:

1. Participants previously vaccinated with GVAX pancreas vaccine. These participants will receive booster vaccinations as a continuation of care. Vaccination repeats every 6 months in the absence of disease progression or unacceptable toxicity.
2. Participants who were not previously vaccinated with GVAX pancreas vaccine (vaccine naive). These participants received priming vaccinations once a month for 3 months followed by booster vaccinations every 6 months.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231-2410
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

1. Inclusion Criteria:

   A. previously vaccinated subjects must receive Gvax vaccine previously

   B. naïve and previously vaccinated subjects must meet the following criteria:

   • have a history of surgically resected pathologic stage 1,2 or 3 adenocarcinoma of the head, neck, tail, or uncinate of the pancreas
   • received the last anti-cancer therapy at least 28 days ago.
   • provide informed consent.
   • have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
   • have adequate hematologic function (Hemoglobin ≥ 9 gm/dl, Absolute neutrophil count (ANC) ≥ 1500 #/cu mm, platelets ≥100,000 K/cu mm)
   • have adequate renal function (Serum creatinine ≤ 2 mg/dL).
   • have adequate hepatic function (Bilirubin ≤ 2.0 mg/dL, unless known Gilbert's Syndrome; Aspartate Aminotransferase (AST), Alanine transaminase (ALT) and amylase ≤ 2x upper limit of normal: Alk Phosphatase ≤ 5x upper limit of normal.)
   • agree to use adequate birth control, if of childbearing potential.

2. Exclusion criteria:

   • radiographical evidence of pancreatic cancer disease recurrence
   • documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis
   • uncontrolled medical problems
   • systemic steroid therapy within 28 days before vaccine administration
   • anticipated need for systemic steroid therapy within 28 days after vaccine administration
   • evidence of active infections
   • pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Previously Vaccinated With GVAX Pancreas Vaccine; Participants receive booster vaccination every 6 months, given intradermally.	Biological: GVAX pancreas vaccine; Given intradermally; Other Names: Two irradiated allogeneic pancreatic tumor cells transfected with the GM-CSF gene
Experimental: GVAX Pancreas Vaccine Naive; Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.	Biological: GVAX pancreas vaccine; Given intradermally; Other Names: Two irradiated allogeneic pancreatic tumor cells transfected with the GM-CSF gene

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity	When calculating the incidences of adverse events, each adverse event (as defined by NCI CTCAE v3) will be counted only once for a given subject.	14 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.	16 years
Disease-free Survival (DFS)	DFS is defined as the time from the first dose until evidence of disease recurrence or progression confirmed by first scan. DFS will be censored at the date of the last scan for subjects without documentation of disease recurrence or progression at the time of analysis. Estimation based on the Kaplan-Meier curve.	16 years

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: National Cancer Institute (NCI); The Skip Viragh Foundation
• Investigators: Principal Investigator: Daniel A. Laheru, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2006
• Primary Completion (Actual): October 11, 2021
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: October 18, 2006
• First Submitted That Met QC Criteria: October 18, 2006
• First Posted (Estimated): October 19, 2006

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: adjuvant therapy; adenocarcinoma of the pancreas; cancer vaccine; GVAX; stage I pancreatic cancer; stage II pancreatic cancer; pancreatic neoplasm; stage IIl pancreatic cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Gastrointestinal Agents; Pancrelipase
• Other Study ID Numbers: J0619; P30CA006973 (U.S. NIH Grant/Contract); JHOC-SKCCC-J0619 (JHM IRB); NA_00002731