Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer

NCT00389610 | Completed Phase 2 Results DMC

• 4 other identifiers: J0619P30CA006973JHOC-SKCCC-J0619NA_00002731
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Keywords

stage I pancreatic cancer; stage II pancreatic cancer; pancreatic neoplasm; adenocarcinoma of the pancreas; stage IIl pancreatic cancer; adjuvant therapy; cancer vaccine; GVAX

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival (OS)

  16 years

• Disease-free Survival (DFS)

  16 years

Study Arms (2)

Previously Vaccinated With GVAX Pancreas Vaccine

EXPERIMENTAL

Participants receive booster vaccination every 6 months, given intradermally.

Biological: GVAX pancreas vaccine

GVAX Pancreas Vaccine Naive

EXPERIMENTAL

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

Interventions

GVAX pancreas vaccine BIOLOGICAL

Given intradermally

Also known as: Two irradiated allogeneic pancreatic tumor cells transfected with the GM-CSF gene

GVAX Pancreas Vaccine Naive; Previously Vaccinated With GVAX Pancreas Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• The Skip Viragh Foundation: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Daniel Laheru, MD
• Organization: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

laherda@jhmi.edu

410-955-8974

Study Officials

• Daniel A. Laheru, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 19, 2006
• Study Start: September 11, 2006
• Primary Completion: October 11, 2021
• Study Completion: December 10, 2022
• Last Updated: October 26, 2023
• Results First Posted: September 2, 2022

Record last verified: 2023-10

Locations

US (1)