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Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer

NCT00103142 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2015-10-14

Study results available
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Summary

RATIONALE: Vaccines made from a gene-modified virus and a person's white blood cells may make the body build an effective immune response to kill tumor cells. Biological therapies, such as Granulocyte-macrophage colony-stimulating factor (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing. Combining different types of biological therapies may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying giving vaccine therapy together with dendritic cells to see how well it works compared to giving vaccine therapy together with GM-CSF in treating patients with liver or lung metastases from colorectal cancer removed by surgery.

Conditions

Interventions

BIOLOGICAL

falimarev

Given subcutaneously and intradermally

BIOLOGICAL

inalimarev

Given subcutaneously and intradermally

BIOLOGICAL

sargramostim

Given subcutaneously

BIOLOGICAL

therapeutic autologous dendritic cells

Given subcutaneously and intradermally

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Michael Morse, MD

    lead OTHER

Principal Investigators

  • Michael A. Morse, MD · Duke Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2009-06-30
Completion
2013-03-31

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 NCT00103142 on ClinicalTrials.gov