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Vaccine Therapy in Treating Patients With Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Antigen Express, Inc.
Norwell, Inc.
Information provided by (Responsible Party):
COL George Peoples, MD, FACS, San Antonio Military Medical Center
ClinicalTrials.gov Identifier:
NCT00524277
First received: August 31, 2007
Last updated: December 31, 2013
Last verified: December 2013
  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 2

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:


Further study details as provided by San Antonio Military 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 every six months 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: December 2015
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524277

Locations
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Hawaii
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
United States, Maryland
MedStar Good Samaritan Hospital Cancer Center
Baltimore, Maryland, United States, 21239
MedStar Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Texas
Carl R. Darnall Army Medical Center
Fort Hood, Texas, United States, 76544-4752
San Antonio Army Medical Center
Fort Sam Houston, Texas, United States, 78234-6200
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
STOH Clinical Research
San Antonio, Texas, United States, 78229
United States, Washington
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States, 98431-5000
Germany
Landstuhl Regional Medical Center
Landstuhl, Kirchberg, Germany, 66849
Greece
Saint Savas Cancer Hospital of Athens
Athens, Greece, 11522
Sponsors and Collaborators
San Antonio Military Medical Center
Antigen Express, Inc.
Norwell, 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:
Publications:
Responsible Party: COL George Peoples, MD, FACS, Chief, Surgical Oncology, Brooke Army Medical Center; Director and Principal Investigator, Cancer Vaccine Development Program, San Antonio Military Medical Center
ClinicalTrials.gov Identifier: NCT00524277     History of Changes
Other Study ID Numbers: CDR0000562261, BAMC-C.2007.098, WRNMMC-20225
Study First Received: August 31, 2007
Last Updated: December 31, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by San Antonio Military 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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014