Multi-epitope Folate Receptor Alpha Peptide Vaccine, Sargramostim, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer

Description

This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide work in treating patients with triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide may work better in treating patients with triple negative breast cancer.

Study Start Date

March, 31 2017

Estimated Completion Date

July 2021

Interventions

  • Biological: Multi-epitope Folate Receptor Alpha Peptide Vaccine
  • Biological: Sargramostim
  • Other: Laboratory Biomarker Analysis
  • Drug: Cyclophosphamide
  • Other: Placebo

Study ID

Academic and Community Cancer Research United -- RU011501I

Status

Recruiting

Trial ID

NCT03012100

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

280

Sponsor

Academic and Community Cancer Research United

Inclusion Criteria

  • Completely resected unilateral or bilateral primary carcinoma of the breast without clinical evidence of disease, negative for estrogen receptor (ER) and progesterone receptor (PR) (cut-off for positivity is > 1% positive tumor cells with nuclear staining), and negative for HER2 as defined by one of the four situations delineated below:
  • HER2 immunohistochemistry (IHC) expression of 0 or 1+ and in-situ hybridization non-amplified
  • HER2 IHC expression of 0 or 1+ and in-situ hybridization not done
  • HER2 IHC expression of 2+ and in-situ hybridization non-amplified
  • IHC not done and in-situ hybridization non-amplified
  • Note: central review is not required
  • Completed planned breast surgeries and any radiation therapy >= 30 days prior to randomization
  • Completed last cycle of chemotherapy (which can be given in the adjuvant and/or neoadjuvant setting) >= 60 days but not >= 365 days prior to randomization
  • Patient has at least one of the following:
  • Pathologic N1-3
  • Pathologic T3
  • Neoadjuvant chemotherapy and did not achieve pathologic response at time of surgery
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1
  • Absolute neutrophil count (ANC) >= 1500/mm^3
  • Platelet count >= 75,000/uL
  • Aspartate transaminase (AST) =< 3 x upper limit of normal (ULN)
  • Creatinine =< 1.5 x ULN
  • Urine dipstick proteinuria < 2+ or urine protein/creatinine (UPC) ratio =< 1.0
  • Note: patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate =< 1 g of protein in 24 hours
  • Negative serum pregnancy test done =< 14 days prior to randomization, for women of childbearing potential only
  • Provide informed written consent
  • Willing to return to enrolling institution for follow-up
  • Willing to provide tissue and blood samples for correlative research studies

Exclusion Criteria

  • Any of the following:
  • Pregnant women
  • Nursing women
  • Women of childbearing potential who are unwilling to employ adequate contraception
  • Clinical evidence of local recurrence or distant metastases
  • Note: all patients must have either a positron emission tomography (PET)/computed tomography (CT) or a CT of chest, abdomen and pelvis and a bone scan if one or more of these is concerning for distant metastases, follow-up imaging and/or biopsy should be performed to rule out distant metastases prior to randomization
  • Inflammatory breast cancer or tumor with deep adherence or cutaneous invasion
  • Known hypersensitivity reaction to GM-CSF
  • History of auto-immune disease per physician discretion
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Prior secondary malignancy < 5 years prior to consent (except non-melanoma skin cancer or carcinoma in situ of the uterine cervix) or receiving other specific treatment for this cancer (monoclonal antibody, small molecule pathway inhibitor)
  • Treatment with systemic corticosteroid or immune-modulators =< 30 days prior to randomization
  • Concurrent treatment with other experimental drugs or any other systemic anticancer therapy (due to unknown drug-vaccine potential interactions)
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
  • Prior or concurrent use of trastuzumab

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (38)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Rachel Hepp 617-724-0878 etripp@mgh.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Rachel Hepp 617-724-0878 etripp@mgh.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Rachel Hepp 617-724-0878 etripp@mgh.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Rachel Hepp 617-724-0878 etripp@mgh.harvard.edu
MedStar Georgetown University Hospital - Washington, District of Columbia 394.4 miles Paula R Pohlmann 202-687-8921 Paula.R.Pohlmann@gunet.georgetown.edu
MedStar Georgetown University Hospital - Washington, District of Columbia 394.4 miles Paula R Pohlmann 202-687-8921 Paula.R.Pohlmann@gunet.georgetown.edu
MedStar Georgetown University Hospital - Washington, District of Columbia 394.4 miles Paula R Pohlmann 202-687-8921 Paula.R.Pohlmann@gunet.georgetown.edu
MedStar Georgetown University Hospital - Washington, District of Columbia 394.4 miles Paula R Pohlmann 202-687-8921 Paula.R.Pohlmann@gunet.georgetown.edu
Inova Fairfax Hospital - Falls Church, Virginia 401.4 miles Parisa Saifollahi 703-207-0733 Parisa.Saifollahi@inova.org
Inova Fairfax Hospital - Falls Church, Virginia 401.4 miles Parisa Saifollahi 703-207-0733 Parisa.Saifollahi@inova.org
Inova Fairfax Hospital - Falls Church, Virginia 401.4 miles Parisa Saifollahi 703-207-0733 Parisa.Saifollahi@inova.org
University of Chicago Comprehensive Cancer Center - Chicago, Illinois 848.0 miles Simona Olberkyte 773-702-4848 solberkyte@medicine.bsd.uchicago.edu
University of Chicago Comprehensive Cancer Center - Chicago, Illinois 848.0 miles Simona Olberkyte 773-702-4848 solberkyte@medicine.bsd.uchicago.edu
University of Chicago Comprehensive Cancer Center - Chicago, Illinois 848.0 miles Simona Olberkyte 773-702-4848 solberkyte@medicine.bsd.uchicago.edu
University of Chicago Comprehensive Cancer Center - Chicago, Illinois 848.0 miles Simona Olberkyte 773-702-4848 solberkyte@medicine.bsd.uchicago.edu
Carle Cancer Center NCI Community Oncology Research Program - Urbana, Illinois 902.4 miles Christine M Canfield 217-326-1881 christine.canfield@carle.com
Carle Cancer Center NCI Community Oncology Research Program - Urbana, Illinois 902.4 miles Christine M Canfield 217-326-1881 christine.canfield@carle.com
Carle Cancer Center NCI Community Oncology Research Program - Urbana, Illinois 902.4 miles Christine M Canfield 217-326-1881 christine.canfield@carle.com
Carle Cancer Center NCI Community Oncology Research Program - Urbana, Illinois 902.4 miles Christine M Canfield 217-326-1881 christine.canfield@carle.com
Marshfield Clinic - Marshfield, Wisconsin 969.4 miles Seth O Fagbemi 715-389-7542 fagbemi.seth@marshfieldclinic.org
Marshfield Clinic - Marshfield, Wisconsin 969.4 miles Seth O Fagbemi 715-389-7542 fagbemi.seth@marshfieldclinic.org
Marshfield Clinic - Marshfield, Wisconsin 969.4 miles Seth O Fagbemi 715-389-7542 fagbemi.seth@marshfieldclinic.org
Marshfield Clinic - Marshfield, Wisconsin 969.4 miles Seth O Fagbemi 715-389-7542 fagbemi.seth@marshfieldclinic.org
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Lori L Henrichs 507-538-7665 Henrichs.lori@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Lori L Henrichs 507-538-7665 Henrichs.lori@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Lori L Henrichs 507-538-7665 Henrichs.lori@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Lori L Henrichs 507-538-7665 Henrichs.lori@mayo.edu
University of Miami Miller School of MedicineSylvester Cancer Center - Miami, Florida 1,259.8 miles Vivianne M VelezBravo 305-243-3379 vmv42@med.miami.edu
University of Miami Miller School of MedicineSylvester Cancer Center - Miami, Florida 1,259.8 miles Vivianne M VelezBravo 305-243-3379 vmv42@med.miami.edu
University of Miami Miller School of MedicineSylvester Cancer Center - Miami, Florida 1,259.8 miles Vivianne M VelezBravo 305-243-3379 vmv42@med.miami.edu
University of Miami Miller School of MedicineSylvester Cancer Center - Miami, Florida 1,259.8 miles Vivianne M VelezBravo 305-243-3379 vmv42@med.miami.edu
Ochsner Medical Center Jefferson - New Orleans, Louisiana 1,363.3 miles Socea A May 504-842-2373 Socea.may@ochsner.org
Ochsner Medical Center Jefferson - New Orleans, Louisiana 1,363.3 miles Socea A May 504-842-2373 Socea.may@ochsner.org
Ochsner Medical Center Jefferson - New Orleans, Louisiana 1,363.3 miles Socea A May 504-842-2373 Socea.may@ochsner.org
Ochsner Medical Center Jefferson - New Orleans, Louisiana 1,363.3 miles Socea A May 504-842-2373 Socea.may@ochsner.org
Mayo Clinic in Arizona - Scottsdale, Arizona 2,280.6 miles Nicole Ritacca 480-301-4161 Ritacca.Nicole@mayo.edu
Mayo Clinic in Arizona - Scottsdale, Arizona 2,280.6 miles Nicole Ritacca 480-301-4161 Ritacca.Nicole@mayo.edu
Mayo Clinic in Arizona - Scottsdale, Arizona 2,280.6 miles Nicole Ritacca 480-301-4161 Ritacca.Nicole@mayo.edu

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