Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins56 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

GVAX pancreas vaccineBIOLOGICAL

Given intradermally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: 14 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 16 years

Data from ClinicalTrials.gov

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