Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389610
• Other study ID #: J0619
• Secondary ID: P30CA006973JHOC-
• Status: Completed
• Phase: Phase 2
• Start date: September 11, 2006
• Est. completion date: December 10, 2022

Study information

• Verified date: October 2023
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 10, 2022
• Est. primary completion date: October 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• GVAX pancreas vaccine
Given intradermally

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI), The Skip Viragh Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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