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Trial record 4 of 31 for:    IGFBP2

Vaccine to Prevent Recurrence in Patients With HER-2 Positive 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.


Condition or disease Intervention/treatment Phase
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 Biological: DC1 Vaccine Biological: WOKVAC Vaccine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
Actual Study Start Date : February 9, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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

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.

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384914


Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Jesse Hevia    813-745-5151    jesse.hevia@moffitt.org   
Contact: Hyo S. Han, M.D.    813-745-4933    hyo.han@moffitt.org   
Principal Investigator: Hyo S. Han, M.D.         
Sub-Investigator: Brian J. Czerniecki, M.D., Ph.D.         
United States, Washington
University of Washington, Fred Hutchinson Cancer Research Center Not yet recruiting
Seattle, Washington, United States, 98109
Contact: (Mary) Nora S. Disis, M.D.    206-616-1823    ndisis@uw.edu   
Principal Investigator: Mary (Nora) Disis, M.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
United States Department of Defense
Investigators
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Principal Investigator: Hyo S. Han, M.D. H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03384914     History of Changes
Other Study ID Numbers: MCC-19117
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
axillary nodes
HER-2 directed treatment

Additional relevant MeSH terms:
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Breast Neoplasms
Recurrence
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes
Vaccines
Immunologic Factors
Physiological Effects of Drugs