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Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery

NCT00669734 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-23

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of vaccine therapy when given together with sargramostim in treating patients with locally advanced or metastatic pancreatic cancer that cannot be removed by surgery. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy directly into the tumor together with sargramostim may cause a stronger immune response and kill more tumor cells.

Conditions

  • Locally Advanced Pancreatic Adenocarcinoma
  • Pancreatic Acinar Cell Carcinoma
  • Pancreatic Ductal Adenocarcinoma
  • Stage III Pancreatic Cancer AJCC v6 and v7
  • Stage IV Pancreatic Cancer AJCC v6 and v7

Interventions

BIOLOGICAL

Falimarev

Given intratumorally or SC

BIOLOGICAL

Inalimarev

Given SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Sargramostim

Given SC

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Elizabeth A Poplin · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-01
Primary Completion
2021-09-02
Completion
2027-04-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00669734 on ClinicalTrials.gov