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A Dose-Escalation Vaccine Trial In HER2-Overexpressing Patients With High-Risk Breast Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00058526
  Purpose

This trial will test how safe this vaccine is. It also tests whether its introduction induces an immune response by stimulating the patient's own immune system to recognize a specific target molecule called HER2, which is overexpressed in many breast cancers.

The vaccine in this trial has not previously been administered to humans, and therefore the induction of the desired immune responses in humans remains to be established. Patients will receive 6 intramuscular vaccinations over a 14 week period, with 9 clinic visits and 3 follow up visits. In addition, patients are asked to revisit the study physician once a year for 5 years after the study ends to evaluate any long-term effects.


Condition Intervention Phase
Breast Cancer
Biological: Investigational Cancer Vaccine
Phase I

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety Study
Official Title:   A Multicenter Phase I Open-Label Dose-Escalation Vaccine Trial of dHER2 Protein With AS15 Adjuvant in HER2-Overexpressing Patients With High-Risk Breast Cancer

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:   18
Study Start Date:   January 2003

  Eligibility
Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion criteria:

  • Provide written informed consent.
  • Previous diagnosis of HER2/neu-positive breast cancer.
  • Stage II with 4 or more positive nodes, or Stage III in remission.
  • Have had standard treatment for their cancer, including lymph node dissection and at least one course of standard adjuvant treatment with or without local-regional breast irradiation.
  • Free of recurrent breast cancer disease.
  • Current chest X-ray showing no evidence of disease.
  • Completed at least one course of standard adjuvant treatment within 2 years of study entry.
  • Life expectancy of at least 12 months.

Exclusion criteria:

  • Surgery or chemotherapy treatment within 8 weeks of study enrollment.
  • Radiotherapy within 12 weeks of study enrollment.
  • Use of other experimental agents during study.
  • Use of investigational or commercial agents or therapies intended to treat the malignancy during the study or within 1 month prior to first study vaccination.
  • Patients younger than 40 years of age must be sterile or incapable of childbearing.
  • Heart problems or uncontrolled hypertension, bleeding or coagulation disorders, auto-immune disorders, or psychiatric illness or addictive disorders.
  • Known to be HIV positive.
  • Past or current treatment with drug Herceptin.
  • Pregnant or breastfeeding.
  • Any uncontrolled illness that would preclude the study.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058526

Locations
United States, California
Study Site    
      Greenbrae, California, United States, 94904
United States, Florida
Study Site    
      Hollywood, Florida, United States, 33324
Study Site    
      Plantation, Florida, United States, 33324
United States, Kentucky
Study Site    
      Louisville, Kentucky, United States, 40202
United States, Minnesota
Study Site    
      Rochester, Minnesota, United States, 55905
United States, New York
Study Site    
      Buffalo, New York, United States, 14263
United States, North Carolina
Study Site    
      Charlotte, North Carolina, United States, 28203
United States, Pennsylvania
Study Site    
      Philadelphia, Pennsylvania, United States, 19111
United States, Washington
Study Site    
      Seattle, Washington, United States, 98195
Australia, Victoria
Study Site    
      Footscray, Victoria, Australia, VIC 3011
Study Site    
      Parkville, Victoria, Australia, VIC 3050
Study Site    
      Heidelberg, Victoria, Australia, VIC 3084
Study Site    
      East Melbourne, Victoria, Australia, VIC 3002
Belgium
Study Site    
      Brussels, Belgium, B-1000
Study Site    
      Leuven, Belgium, B-3000
Study Site    
      Brussels, Belgium, B-1200
Study Site    
      Leuven, Belgium, B-3000
Belgium, Hainaut
Study Site    
      Charleroi, Hainaut, Belgium, B-6000
France
Study Site    
      Nantes-St-Herblain, France, F-44805
Study Site    
      Lyon Cedex 08, France, F-69 373
Study Site    
      Paris Cedex 05, France, F-75 248
Italy
Study Site    
      Perugia, Italy, I-06122
Study Site    
      Roma, Italy, I-00161
Study Site    
      Milano, Italy, I-20141

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials     GlaxoSmithKline    
  More Information


Study ID Numbers:   719125/002
First Received:   April 7, 2003
Last Updated:   September 27, 2006
ClinicalTrials.gov Identifier:   NCT00058526
Health Authority:   United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
dHER-AS15-002  

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 30, 2008




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