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Vaccine Therapy in Treating Patients With Breast Cancer
This study is currently recruiting participants.
Verified July 2011 by Walter Reed Army Medical Center

First Received on August 31, 2007.   Last Updated on July 28, 2011   History of Changes
Sponsor: Brooke Army Medical Center
Collaborator: Antigen Express, Inc.
Information provided by: Walter Reed Army Medical Center
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: GP2 peptide + GM-CSF vaccine
Biological: GM-CSF (sargramostim)
Biological: AE37 + GM-CSF vaccine
 Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Phase II Trial of the HER2/Neu Peptide GP2 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2+ OR the Modified HER2/Neu Peptide AE37 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim
U.S. FDA Resources

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • Disease recurrence [ Time Frame: Five years (from date of enrollment to the study through the end of the follow-up period) ] [ Designated as safety issue: No ]

    The following will be compared:

    1. disease recurrence rates between HLA-A2-negative patients receiving the AE37 + GM-CSF vaccine and HLA-A2-negative patients receiving GM-CSF alone
    2. disease recurrence rates between HLA-A2-positive patients receiving the GP2 + GM-CSF vaccine and HLA-A2-positive patients receiving GM-CSF alone
    3. disease recurrence rates between all four arms of the trial.


Secondary Outcome Measures:
  • Safety [ Time Frame: Local and systemic reactions to each inoculation will be monitored during the regular inoculation series and the booster series ] [ Designated as safety issue: Yes ]
    Inoculations will be immediately halted if any serious adverse reactions occur which, when based upon appropriate judgment of the PI, are determined to jeopardize the patient or require medical or surgical intervention. Any death or grade 4 adverse drug experience found to be directly related to the experimental vaccine will result in suspension of patient enrollment to the study.

  • Immune Response [ Time Frame: Immune response will be measured after every monthly inoculation in the regular inoculation series and after each inoculation in the booster series ] [ Designated as safety issue: No ]
    Immune response will be measured by proliferation assays, dimer assays, and ELISPOT. Delayed type hypersensitivity reactions will be compared between the vaccinated group and GM-CSF-only group.


Estimated Enrollment: 600
Study Start Date: January 2007
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Biological: GP2 peptide + GM-CSF vaccine
Given intradermally every 3-4 weeks for a total of up to 6 inoculations
Other Name: GM-CSF (sargramostim)
Active Comparator: Arm II
HLA-A2-positive patients receive GM-CSF ID every 3-4 weeks for a total of up to 6 inoculations.
 Biological: GM-CSF (sargramostim)
GM-CSF given intradermally very 3-4 weeks for a total of up to 6 inoculations
Other Name: GM-CSF (sargramostim)
Experimental: Arm III
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 + GM-CSF vaccine
Given intradermally every 3-4 weeks for a total of up to 6 inoculations
Other Name: GM-CSF (sargramostim)
Active Comparator: Arm IV
HLA-A2-negative patients receive GM-CSF ID ID every 3-4 weeks for a total of up to 6 inoculations
 Biological: GM-CSF (sargramostim)
Given intradermally every 3-4 weeks for a total of up to 6 inoculations
Other Name: GM-CSF (sargramostim)

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 invitro and invivo 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 4 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.
  • Arm II: HLA-A2-positive patients receive solely GM-CSF ID
  • Arm III: HLA-A2-negative patients receive AE37 peptide/GM-CSF vaccine ID every 3-4 weeks for a total of up to 6 inoculations.
  • Arm IV: HLA-A2-negative patients receive solely GM-CSF ID

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.

Booster inoculations are administered at 12, 18, 24, and 30 months from the date of patients' enrollment into the study. One booster inoculation is administered at each timepoint (+/- 2 weeks) and will be the same inoculation (vaccine or GM-CSF only) as what patients received during their regular inoculation series.

  Eligibility

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

DISEASE CHARACTERISTICS:

Inclusion criteria:

  1. Lymph node-positive breast cancer or high-risk lymph node-negative breast cancer. The latter is defined by any one of the following criteria:

    • T2 disease
    • Grade 3 disease
    • Lymphovascular invasion
    • Estrogen receptor- or progesterone receptor-negative disease
    • HER2/neu-expressing tumor (immunohistochemistry [IHC] 3+ and/or amplified fluorescence in situ hybridization [FISH] >2.2, or N0 (i+))
  2. HER2/neu-expressing tumor (IHC 1-3+ and or positive FISH >1.2)
  3. Completion 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)
  4. Clinically cancer-free (no evidence of disease)
  5. Patients may be enrolled between 1-6 months from completion of standard primary breast cancer therapies
  6. Good performance status (as defined in Exclusion Criteria)
  7. Capable of informed consent

Exclusion criteria:

  1. HER2/neu-negative breast cancers (IHC 0)
  2. Clinical and/or radiographic evidence of residual or persistent breast cancer
  3. Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
  4. In poor health (Karnofsky <60%, ECOG >/-2)
  5. Total bilirubin >1.8, creatinine >2, hemoglobin <10, platelets <50,000, WBC <2,000)
  6. Active interstitial lung disease; asthma requiring more than as needed bronchodilators for management; or other autoimmune lung disease
  7. Pregnancy (urine hCG)
  8. Breast feeding
  9. History of autoimmune disease
  10. Involved in other experimental protocols (except with permission of the other study PI)

PATIENT CHARACTERISTICS:

Inclusion criteria:

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

Exclusion criteria:

  • 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

Contacts
Contact: Diane M Papay, BS, RN 202-782-3877 diane.marie.papay@us.army.mil
Contact: Joyce A Winters, BSN, RN 202-782-4222 JOYCE.WINTERS@US.ARMY.MIL

Locations
United States, District of Columbia
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Ruth Chamberlain, RN, BSN     202-537-4000     RChamberlain@sibley.org    
Contact: Leslie Greendberg, RN, MSN, OCN     202-243-2320     LGreenberg@sibley.org    
Principal Investigator: Meredith G. Garrett, MD            
Sub-Investigator: Bruce Kressel, MD            
Sub-Investigator: Ari Fishman, MD            
Sub-Investigator: Frederick Smith, MD            
Sub-Investigator: Frederick Barr, MD            
Sub-Investigator: Collette Magnant, MD            
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307-5001
Contact: Diane M Papay, BS, RN     202-782-3877     diane.marie.papay@us.army.mil    
Contact: Joyce A Winters, BSN, RN     202-782-4222     JOYCE.WINTERS@US.ARMY.MIL    
Principal Investigator: MAJ(P) Tanya M. Wroblewski, MD            
Sub-Investigator: LTC Peter Andreas Lindenberg, MD            
United States, Hawaii
University of Hawaii Cancer Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Elsa Villarreal     808-564-5822     evillarreal@cc.hawaii.edu    
Contact: Debbie Bielecki, MS     808-586-2978     debielecki@cc.hawaii.edu    
Principal Investigator: Jonathan K Cho, MD            
Sub-Investigator: Michelle Miyashiro, MD            
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    
Principal Investigator: John Stewart, IV, MD            
Sub-Investigator: Perry Shen, MD            
Sub-Investigator: Edward Levine, MD            
United States, Texas
Carl R. Darnall Army Medical Center Recruiting
Fort Hood, Texas, United States, 76544-4752
Contact: Edna Figueroa-Dias, RN     254-288-8048     Edna.Figueroa-Dias@AMEDD.ARMY.MIL    
Principal Investigator: COL Sonja M. Thompson, MD            
Brooke Army Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234-6200
Contact: Karen L Escamilla, BSN, RN     210-916-4837     karen.l.escamilla.ctr@us.army.mil    
Contact: COL George E Peoples, MD, FACS     210-916-1117     george.peoples@us.army.mil    
Principal Investigator: MAJ Nate Shumway, DO            
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-4009
Contact: Ilona Hood, RN     713-563-0721     IUHood@mdanderson.org    
Contact: Sara E. Stassen, RN, BSN     713-563-1681     SEStassen@mdanderson.org    
Principal Investigator: Elizabeth A Mittendorf, MD            
Sub-Investigator: Ricardo Alvarez, MD            
Sub-Investigator: Banu Arun, MD            
Sub-Investigator: Robert Bast, Jr, MD            
Sub-Investigator: Daniel Booster, MD            
Sub-Investigator: Abenaa Brewster, MD            
Sub-Investigator: Aman Buzdar, MD            
Sub-Investigator: Massimo Cristofanilli, MD            
Sub-Investigator: Francisco Esteva, MD            
Sub-Investigator: Sharon Giordano, MD            
Sub-Investigator: Ana Maria Gonzalez-Angulo, MD            
Sub-Investigator: Marjorie Green, MD            
Sub-Investigator: Gabriel Hortobagyi, MD            
Sub-Investigator: Nuhad Ibrahim, MD            
Sub-Investigator: Kimberly Koenig, MD            
Sub-Investigator: Jennifer Litton, MD            
Sub-Investigator: Amal Melhem-Bertrandt, MD            
Sub-Investigator: Phuong Khanh Morrow, MD            
Sub-Investigator: Stacy Moulder, MD            
Sub-Investigator: Lajos Pusztai, MD            
Sub-Investigator: Richard Theriault, DO            
Sub-Investigator: Naoto Ueno, MD            
Sub-Investigator: Vicente Valero, MD            
Sub-Investigator: Ronald Walters, MD            
STOH Clinical Research Recruiting
San Antonio, Texas, United States, 78229
Contact: Lacey Frank, RN, BSN     210-593-5725     lacey.frank@stoh.com    
Contact: Erin Miller, RN, CRC     210-593-2572     erin.miller@stoh.com    
Principal Investigator: Gladys Rodriguez, MD            
United States, Washington
Madigan Army Medical Center - Tacoma Recruiting
Tacoma, Washington, United States, 98431-5000
Contact: Shari Aynes, RN, CCRC     253-968-3891     shari.aynes1@us.army.mil    
Principal Investigator: Richard Reed, MD            
Sub-Investigator: David E McCune, MD            
Sub-Investigator: Anthony Fadell, MD            
Sub-Investigator: Louise C Waszak, PhD, ARNP            
Germany
Landstuhl Regional Medical Center Recruiting
Landstuhl, Kirchberg, Germany, 66849
Contact: LTC Mark Carmichael, MD     011-49-6371-86-7309     Mark.Carmichael@amedd.army.mil    
Contact: Andrien Schwartz, RN, BSN, OCN         Andrien.Schwartz@AMEDD.ARMY.MIL    
Principal Investigator: LTC Mark Carmichael, MD            
Greece
Saint Savas Cancer Hospital of Athens Recruiting
Athens, Greece, 11522
Contact: Alexandros Ardavanis, MD     +30-210-6409508     ardavanis@yahoo.com    
Contact: Sonia Perez, PhD     +30-210-6409459     perez@ciic.gr    
Principal Investigator: Alexandros Ardavanis, MD            
Sub-Investigator: Sonia Perez, PhD            
Sponsors and Collaborators
Brooke Army Medical Center
Antigen Express, Inc.
Investigators
Principal Investigator: Elizabeth A Mittendorf, MD, FACS UT M.D. Anderson Cancer Center
Study Director: George E Peoples, MD, FACS Cancer Vaccine Development Program, Department of Surgery, Brooke Army Medical Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Mittendorf EA, Alatrash G, Xiao H, Clifton GT, Murray JL, Peoples GE. Breast cancer vaccines: ongoing National Cancer Institute-registered clinical trials. Expert Rev Vaccines. 2011 Jun;10(6):755-74.

Responsible Party: COL George E. Peoples, MC, Cancer Vaccine Development Program, Department of Surgery, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT00524277     History of Changes
Other Study ID Numbers: CDR0000562261, BAMC-C.2007.098, WRAMC-20225
Study First Received: August 31, 2007
Last Updated: July 28, 2011
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by Walter Reed Army Medical Center:
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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012



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