Adjuvant GVAX Vaccine Therapy In Patients With Pancreatic Cancer

Study Overview

Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer

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.

Pancreatic Cancer

BIOLOGICAL: GVAX pancreas vaccine

J0619
P30CA006973 (U.S. NIH Grant/Contract)
JHOC-SKCCC-J0619
NA_00002731

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-10-18	Results First Submitted 2022-08-09	Last Update Submitted that met QC Criteria 2023-10-24
First Submitted that Met QC Criteria 2006-10-18	Results First Submitted that Met QC Criteria 2022-08-09	Last Update Posted (ACTUAL) 2023-10-26
First Posted (ACTUAL) 2006-10-19	Results First Posted 2022-09-02	Last Verified 2023-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

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
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

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

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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

The Skip Viragh Foundation
National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Daniel A. Laheru, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record