NCT00524277

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
456

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_2 breast-cancer

Geographic Reach
3 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

8 years

First QC Date

August 31, 2007

Last Update Submit

March 23, 2020

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancermale breast cancer

Outcome Measures

Primary Outcomes (1)

  • Disease recurrence

    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.

    Five years (from date of enrollment to the study through the end of the follow-up period)

Secondary Outcomes (2)

  • Safety

    Local and systemic reactions to each inoculation will be monitored every six months during the regular inoculation series and the booster series.

  • Immune Response

    Immune response will be measured after every monthly inoculation in the regular inoculation series and after each inoculation in the booster series

Study Arms (4)

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.

Biological: GP2 peptide + GM-CSF vaccine

Arm II

ACTIVE COMPARATOR

HLA-A2-positive patients receive GM-CSF ID every 3-4 weeks for a total of up to 6 inoculations.

Biological: GM-CSF (sargramostim)

Arm III

EXPERIMENTAL

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

Arm IV

ACTIVE COMPARATOR

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)

Interventions

GP2 peptide + GM-CSF vaccineBIOLOGICAL

Given intradermally every 3-4 weeks for a total of up to 6 inoculations

Also known as: GM-CSF (sargramostim)
Arm I
GM-CSF (sargramostim)BIOLOGICAL

GM-CSF given intradermally very 3-4 weeks for a total of up to 6 inoculations

Arm II
AE37 + GM-CSF vaccineBIOLOGICAL

Given intradermally every 3-4 weeks for a total of up to 6 inoculations

Also known as: GM-CSF (sargramostim)
Arm III

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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+))
  • HER2/neu-expressing tumor (IHC 1-3+ and or positive FISH \>1.2)
  • 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)
  • Clinically cancer-free (no evidence of disease)
  • Patients may be enrolled between 1-6 months from completion of standard primary breast cancer therapies

You may not qualify if:

  • Capable of informed consent
  • HER2/neu-negative breast cancers (IHC 0)
  • Clinical and/or radiographic evidence of residual or persistent breast cancer
  • Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
  • In poor health (Karnofsky \<60%, ECOG \>/-2)
  • Total bilirubin \>1.8, creatinine \>2, hemoglobin \<10, platelets \<50,000, WBC \<2,000)
  • Active interstitial lung disease; asthma requiring more than as needed bronchodilators for management; or other autoimmune lung disease
  • Pregnancy (urine hCG)
  • Breast feeding
  • History of autoimmune disease
  • Involved in other experimental protocols (except with permission of the other study PI)
  • PATIENT CHARACTERISTICS:
  • Female or male
  • Menopausal status not specified
  • Immunologically intact by recall anergy testing
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

MedStar Good Samaritan Hospital Cancer Center

Baltimore, Maryland, 21239, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Carl R. Darnall Army Medical Center

Fort Hood, Texas, 76544-4752, United States

Location

San Antonio Army Medical Center

Fort Sam Houston, Texas, 78234-6200, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

STOH Clinical Research

San Antonio, Texas, 78229, United States

Location

Madigan Army Medical Center - Tacoma

Tacoma, Washington, 98431-5000, United States

Location

Landstuhl Regional Medical Center

Landstuhl, Kirchberg, 66849, Germany

Location

Saint Savas Cancer Hospital of Athens

Athens, 11522, Greece

Location

Related Publications (3)

  • 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. doi: 10.1586/erv.11.59.

    PMID: 21692698BACKGROUND

  • Sears AK, Perez SA, Clifton GT, Benavides LC, Gates JD, Clive KS, Holmes JP, Shumway NM, Van Echo DC, Carmichael MG, Ponniah S, Baxevanis CN, Mittendorf EA, Papamichail M, Peoples GE. AE37: a novel T-cell-eliciting vaccine for breast cancer. Expert Opin Biol Ther. 2011 Nov;11(11):1543-50. doi: 10.1517/14712598.2011.616889. Epub 2011 Sep 6.

    PMID: 21895539RESULT

  • Jackson DO, Trappey FA, Clifton GT, Vreeland TJ, Peace KM, Hale DF, Litton JK, Murray JL, Perez SA, Papamichail M, Mittendorf EA, Peoples GE. Effects of HLA status and HER2 status on outcomes in breast cancer patients at risk for recurrence - Implications for vaccine trial design. Clin Immunol. 2018 Oct;195:28-35. doi: 10.1016/j.clim.2018.06.008. Epub 2018 Jul 17.

    PMID: 30025819DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

Granulocyte-Macrophage Colony-Stimulating Factorsargramostim

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Elizabeth A Mittendorf, MD, FACS

    UT M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

  • George E Peoples, MD, FACS

    Cancer Vaccine Development Program, Department of Surgery, Brooke Army Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Surgical Oncology, Brooke Army Medical Center; Director and Principal Investigator, Cancer Vaccine Development Program

Study Record Dates

First Submitted

August 31, 2007

First Posted

September 3, 2007

Study Start

January 1, 2007

Primary Completion

December 31, 2014

Study Completion

March 31, 2017

Last Updated

March 30, 2020

Record last verified: 2020-03

Locations

GR(1)US(11)DE(1)