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Immunotherapy Vaccine and Herceptin in Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014076
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
George E. Peoples, Cancer Insight, LLC

Tracking Information
First Submitted Date  ICMJE January 4, 2017
First Posted Date  ICMJE January 9, 2017
Last Update Posted Date January 9, 2017
Study Start Date  ICMJE January 2008
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: 12 months ]
Patients receiving treatment will be followed from baseline to completion of study for adverse events using CTCAE v4.0
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunotherapy Vaccine and Herceptin in Breast Cancer
Official Title  ICMJE Phase Ib Trial of Combination Immunotherapy With HER2/Neu Peptide GP2 + GM-CSF Vaccine and Trastuzumab in Breast Cancer Patients
Brief Summary

The purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2 peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. While not a primary endpoint, time to recurrence is measured for enrolled subjects. The objectives of the study are the following:

  • Assess safety and document local and systemic toxicity to combination immunotherapy with GP2 peptide + GM-CSF vaccine and trastuzumab
  • Evaluate the in vitro and in vivo immunologic responses to combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab
  • Determine maximum tolerated dose and optimal biologic dose for the combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breastcancer
Intervention  ICMJE
  • Drug: GP2 peptide + GM-CSF vaccine plus trastuzumab
    HLA-A2+/A3+ subjects are given the GP2 peptide vaccine plus trastuzumab
  • Drug: Trastuzumab
    HLA-A2-/A3- patients are followed as controls receiving trastuzumab only.
    Other Name: Herceptin
Study Arms  ICMJE
  • Experimental: GP2 peptide + GM-CSF + trastuzumab
    HLA-A2+/A3+ subjects receive GP2 + GM-CSF vaccine and trastzumab
    Intervention: Drug: GP2 peptide + GM-CSF vaccine plus trastuzumab
  • Active Comparator: Trastuzumab
    HLA-A2-/A3- subjects followed as controls receiving trastuzumab.
    Intervention: Drug: Trastuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2017)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 years
  • HER2/neu+ over-expressing breast cancer (IHC 3+ or FISH ≥2.0)
  • Patients who are receiving adjuvant trastuzumab as standard of care treatment
  • Completion of breast cancer therapy (i.e., surgery, radiation, and chemotherapy as appropriate per standard of care for patients' specific cancer) to exclude trastuzumab (Patients on oral hormonal therapy as part of their adjuvant breast cancer treatment will be maintained on their regimens.)
  • Enrollment must occur so that patients' trastuzumab treatment and vaccine schedule overlap for all 6 vaccinations and so that first vaccination occurs after a standard of care Multiple Gated Acquisition Scan (MUGA)
  • ECOG performance status (PS) 0-1
  • Clinically cancer-free (no evidence of disease; excluding +CTC)
  • If the patient is of childbearing potential, she must be willing to practice adequate contraception through the study treatment period and for 2 months after completion of the injection sites
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Clinical and/or radiographic evidence of residual or persistent breast cancer
  • Receiving immunosuppressive therapy to include methotrexate or steroids (note: the use of prednisone, or equivalent, <2.0mg/day, is allowed)
  • Tbili >1.8, creatinin >2, hemoglobin <10, platelets <100,000/mm³, WBC <2,000
  • Active pulmonary disease requiring medication to include multiple inhalers
  • Patients may not be receiving any other investigational agents (except with permission of the Lead Principal Investigator)
  • Pregnant or are nursing
  • History of autoimmune disease (patients with vitiligo not excluded)
  • HIV positive
  • Previous or concomitant malignancies at other sites, except effectively treated non- melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured
  • Other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk
  • Uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrollment
  • Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study or adequate compliance
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03014076
Other Study ID Numbers  ICMJE C.2008.146
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party George E. Peoples, Cancer Insight, LLC
Study Sponsor  ICMJE Cancer Insight, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: George E Peoples, MD Cancer Insight
PRS Account Cancer Insight, LLC
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP