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Trial record 4 of 30 for:    IGFBP2

Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT03384914
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Tracking Information
First Submitted Date  ICMJE December 20, 2017
First Posted Date  ICMJE December 28, 2017
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE February 9, 2018
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
Disease-free Survival (DFS) [ Time Frame: Up to 7 years ]
Clinical activity is characterized by disease-free survival (DFS), defined as the time from start of treatment to documented recurrence (any breast event), death due to any cause or last patient contact that documents recurrence-free status (i.e., a clinic or scan date).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03384914 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
Immunogenicity [ Time Frame: Up to 7 years ]
The primary immunogenicity outcome for both arms of this trial will be the summation of spots (ELISPOT) for 6 distinct peptides and reported as total SFC/10^6 cells. A value >150 defines an immune response.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
Official Title  ICMJE A Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
Brief Summary

The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence (assessed by disease free survival).

Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). The study vaccine will be administered in two phases: a study vaccination phase and a booster phase.

Detailed Description The total duration of the study will be 6 years (4 years of patient enrollment and 2 additional years of clinical follow-up). Assessment for disease recurrence and survival will be conducted every 6 months (with a phone call/secure email, medical records or follow up visit) from the end of treatment for a total of 2 years, until the completion of the trial or until documented disease recurrence.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer Female
  • Breast Cancer, Male
  • Breast Cancer Stage I
  • Breast Cancer Stage II
  • Breast Cancer Stage III
  • Residual Disease
  • HER2-positive Breast Cancer
  • HER2 Positive Breast Carcinoma
Intervention  ICMJE
  • Biological: DC1 Vaccine

    Vaccination Phase: DC1 vaccine will be administered weekly via intranodal injection in weeks 1 to 6 (window 8-21days between vaccines).

    Booster vaccines will be administered at approximately 3 month intervals on months 6, 9 and 12 (with a window +/- 1 month).

    Other Names:
    • Immunotherapy
    • Dendritic Cell Vaccine
  • Biological: WOKVAC Vaccine

    Vaccination Phase: WOKVAC vaccine will be administered via intradermal injection on weeks 1, 4 and 7 (window +21 days).

    Booster vaccines will be administered at approximately 3 month intervals on months 6, 9 and 12 (with a window +/- 1 month).

    Other Names:
    • Immunotherapy
    • pUMVC3-IGFBP2-HER2-IGF1R
Study Arms  ICMJE
  • Active Comparator: Dendritic Cell (DC1) Vaccine

    The vaccine will be administered in two phases: a vaccination phase and a booster phase.

    Approximately 6 months from the initiation of the first vaccine, patients will receive the first of 3 booster vaccines.

    Intervention: Biological: DC1 Vaccine
  • Active Comparator: pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC)

    The vaccine will be administered in two phases: a vaccination phase and a booster phase.

    Approximately 6 months from the initiation of the first vaccine, patients will receive the first of 3 booster vaccines.

    Intervention: Biological: WOKVAC Vaccine
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 20, 2017)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical stage I-III HER2 positive breast cancer treated with neoadjuvant chemotherapy including HER-2 directed treatment for at least 12 weeks.
  • Residual invasive carcinoma in the breast or axillary nodes in the final pathology from resected tumor following neoadjuvant chemotherapy.
  • Completed last cycle of cytotoxic chemotherapy or radiation > 30 days with resolution of all acute toxic effects of prior therapy to grade ≤ 2 (except alopecia)
  • Less than 6 months from the completion of last trastuzumab maintenance infusion.
  • Age ≥ 18 years.
  • Eastern Cooperative Group (ECOG) performance status 0 or 1.
  • Must have normal organ and marrow function as defined below within 2 weeks of registration:

    • Absolute neutrophil count (ANC) ≥ 1,500/ μL
    • Platelets ≥ 75,000/ μL
    • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be <3.0 mg/dL
    • AST/ALT ≤ 3 x institutional upper limit of normal (ULN)
    • Creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
    • Hemoglobin A1C <6.5%
  • Left ventricular ejection fraction (LVEF) above institutional lower limit of normal (by echocardiogram or MUGA scan within 90 days of registration).
  • Females of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and males must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for three months following the last dose.
  • Ability to understand and willingness to sign a written informed consent document prior to initiation of any screening or study-specific procedures.

Exclusion Criteria:

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congenital prolonged QT syndrome, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Uncontrolled autoimmune disease requiring active systemic treatment.
  • Known hypersensitivity reaction to the Granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contraindication to GM-CSF.
  • Pregnant or breast feeding.
  • Known HIV-positive.
  • Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared.
  • Major surgery within 4 weeks of initiation of study drug.
  • Current use of immunosuppressive agents or systemic corticosteroids. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. Patients who have received systemic corticosteroids ≤ 30days prior to starting study drug will be excluded.
  • Potential participant is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03384914
Other Study ID Numbers  ICMJE MCC-19117
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Hyo S. Han, M.D. H. Lee Moffitt Cancer Center and Research Institute
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date July 2019

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