Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer

NCT ID: NCT00389610

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-11
• Study Completion Date: 2022-12-10

Brief Summary

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

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Previously Vaccinated With GVAX Pancreas Vaccine

Participants receive booster vaccination every 6 months, given intradermally.

Group Type: EXPERIMENTAL

GVAX pancreas vaccine

Intervention Type: BIOLOGICAL

Given intradermally

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.

Group Type: EXPERIMENTAL

GVAX pancreas vaccine

Intervention Type: BIOLOGICAL

Given intradermally

Interventions

GVAX pancreas vaccine

Given intradermally

Intervention Type: BIOLOGICAL

Other Intervention Names

Two irradiated allogeneic pancreatic tumor cells transfected with the GM-CSF gene

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Skip Viragh Foundation

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel A. Laheru, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JHOC-SKCCC-J0619

Identifier Type: -

Identifier Source: secondary_id

NA_00002731

Identifier Type: -

Identifier Source: secondary_id

J0619

Identifier Type: -

Identifier Source: org_study_id