Full Text View
Tabular View
No Study Results Posted
Related Studies
Vaccine Therapy in Treating Patients With Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: August 31, 2007   Last Updated: June 16, 2009   History of Changes
Sponsor: Walter Reed Army Medical Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00524277
  Purpose

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy is more effective than GM-CSF in treating breast cancer.

PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with GM-CSF in treating patients with breast cancer.


Condition Intervention Phase
Breast Cancer
Biological: AE37 peptide/GM-CSF vaccine
Biological: GP2 peptide/GM-CSF vaccine
Biological: sargramostim
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind
Official Title: Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/Neu Peptide GP2 + GM-CSF Vaccine Versus GM-CSF Alone in HLA-A2+ OR the Modified HER2/Neu Peptide AE37 + GM-CSF Vaccine Versus GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease recurrence [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: January 2007
Arms Assigned Interventions
Arm I: Experimental

HLA-A2-positive patients receive GP2 peptide/GM-CSF vaccine

intradermally (ID) every 3-4 weeks for a total of up to 6 inoculations. HLA-A2-negative patients receive AE37 peptide/GM-CSF vaccine ID every 3-4 weeks for a total of up to 6 inoculations.

Biological: AE37 peptide/GM-CSF vaccine
Given intradermally
Biological: GP2 peptide/GM-CSF vaccine
Given intradermally
Arm II: Active Comparator
Patients receive GM-CSF ID every 3-4 weeks for a total of up to 6 inoculations.
Biological: sargramostim
Given intradermally

Detailed Description:

OBJECTIVES:

  • To determine if the GP2 peptide/GM-CSF vaccine reduces the recurrence rate in HLA-A2-positive, HER2/neu-positive, node-positive, or high-risk node-negative breast cancer patients randomized to receive the vaccine versus the immunoadjuvant, sargramostim (GM-CSF), alone.
  • To determine if the AE37 peptide/GM-CSF vaccine reduces the recurrence rate in HLA-A2-negative, HER2/neu-positive, node-positive or high-risk node-negative breast cancer patients randomized to receive the vaccine versus the immunoadjuvant, GM-CSF, alone.
  • To monitor the in vitro and in vivo immunologic responses to the vaccines and correlate these responses with the clinical outcomes.
  • To monitor for any unexpected toxicities with the vaccines.

OUTLINE: This is a multicenter study. Patients are stratified according to nodal status. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: HLA-A2-positive patients receive GP2 peptide/GM-CSF vaccine intradermally (ID) every 3-4 weeks for a total of up to 6 inoculations. HLA-A2-negative patients receive AE37 peptide/GM-CSF vaccine ID every 3-4 weeks for a total of up to 6 inoculations.
  • Arm II : Patients receive GM-CSF ID every 3-4 weeks for a total of up to 6 inoculations.

After completion of study therapy, patients are followed every 3 months for the first 24 months and then every 6 months for an additional 36 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Meets one of the following criteria:

    • Lymph node-positive breast cancer
    • High-risk lymph node-negative breast cancer, defined by any one of the following criteria:

      • T2 disease
      • Grade 3 disease
      • Lymphovascular invasion
      • Estrogen receptor- or progesterone receptor-negative disease
      • N0 (I+) disease
  • HER2/neu-expressing tumor (immunohistochemistry [IHC] 1-3+ and/or positive fluorescence in situ hybridization [FISH] > 1.2)
  • Clinically cancer-free (no evidence of disease) after completion (between 1-6 months ago) of primary standard of care breast cancer therapies (i.e., surgery, chemotherapy, immunotherapy, and radiation therapy as appropriate per standard of care for patients' specific cancer)

Exclusion criteria:

  • HER2/neu-negative breast cancers (IHC 0)
  • Clinical and/or radiographic evidence of residual or persistent breast cancer

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Female or male
  • Menopausal status not specified
  • Immunologically intact by recall anergy testing
  • Negative pregnancy test

Exclusion criteria:

  • Anergic by the Mantoux panel of recall antigens
  • Karnofsky 0-60% or ECOG ≥ 2
  • Total bilirubin > 1.8 g/dL
  • Creatinine > 2.0 g/dL
  • Hemoglobin < 10.0 g/dL
  • Platelet count < 50,000/mm³
  • WBC< 2,000/mm³
  • Active pulmonary disease requiring medication that includes multiple inhalers
  • Pregnancy
  • Breastfeeding
  • History of autoimmune disease

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • See Disease Characteristics

Exclusion criteria:

  • Concurrent immunosuppressive therapy including chemotherapy, steroids, or methotrexate
  • Concurrent participation in another experimental treatment (except with permission of the other study investigator)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524277

Locations
United States, District of Columbia
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Sheila Evans, RN, MS, AOCN     202-243-2320     sevans@sibley.org    
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307-5001
Contact: Diane Papay, RN     202-782-3877        
United States, Hawaii
Tripler Army Medical Center Recruiting
Honolulu, Hawaii, United States, 96859
Contact: Jane Doll, RN     808-433-2857        
United States, North Carolina
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Robin Petro, RN     336-713-4788     rpetro@wfubmc.edu    
United States, Texas
Brooke Army Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234-6200
Contact: Karen Parsons, BSN, RN     210-916-4837        
Carl R. Darnall Army Medical Center Recruiting
Fort Hood, Texas, United States, 76544-4752
Contact: Edna Figueroa-Dias, RN     254-288-8048        
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
Mary Crowley Medical Research Center at Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Clinical Trials Office - Mary Crowley Medical Research Center     214-370-1877        
United States, Washington
Madigan Army Medical Center - Tacoma Recruiting
Tacoma, Washington, United States, 98431-5000
Contact: Shari Aynes, RN, CCRC     253-968-3891        
Germany
Landstuhl Regional Medical Center Recruiting
Landstuhl, Germany, 66849
Contact: Mark G. Carmichael, MD     49-6371-86-8100        
Greece
Saint Savas Cancer Hospital of Athens Recruiting
Athens, Greece, 11522
Contact: Michael Papamichail, MD, PhD     30-210-6409-624     papamichail@ciic.gr    
Sponsors and Collaborators
Walter Reed Army Medical Center
Investigators
Study Chair: George E. Peoples, MD Brooke Army Medical Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000562261, WRAMC-07-20029, WRAMC-9625-1186753655.52
Study First Received: August 31, 2007
Last Updated: June 16, 2009
ClinicalTrials.gov Identifier: NCT00524277     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
male breast cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010