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Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients

NCT00317603 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-04-01

Study results available
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Summary

The purpose of this trial is to test the safety of a vaccine made from a patient's own breast cancer cells, and determine if this vaccine will delay or stop the growth of the cancer. The vaccine is made by genetically modifying a patient's own tumor cells to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) to activate the immune response.

Conditions

Interventions

BIOLOGICAL

Autologous, Lethally Irradiated Breast Cancer Cells

Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out

Sponsors & Collaborators

Principal Investigators

  • Beth Overmoyer, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-01
Primary Completion
2008-05-31
Completion
2021-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00317603 on ClinicalTrials.gov