Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer

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

Detailed Description
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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: 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. 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.

Official Title
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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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Biological: GVAX pancreas vaccine


Participation Criteria
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Eligibility Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Previously Vaccinated With GVAX Pancreas Vaccine<br>Participants receive booster vaccination every 6 months, given intradermally. | Biological: GVAX pancreas vaccine<br>* Given intradermally<br>* Other names: Two irradiated allogeneic pancreatic tumor cells transfected with the GM-CSF gene;|
| Experimental: GVAX Pancreas Vaccine Naive<br>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<br>* Given intradermally<br>* Other names: Two irradiated allogeneic pancreatic tumor cells transfected with the GM-CSF gene;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I pancreatic cancer, stage II pancreatic cancer, pancreatic neoplasm, adenocarcinoma of the pancreas, stage IIl pancreatic cancer, adjuvant therapy, cancer vaccine, GVAX