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Cancer/Testis Antigen Immunotherapy Phase I Study With 740-CTA Vaccinia Virus (rVV-740CTA)

Primary Purpose

Breast Carcinoma

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
rVV-740CTA
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Surgically treated M0 patients with solid tumors
  • Tumor expressing at least one of the vaccine targeted antigens Melanoma-associated antigen (MAGE)-A1, -A2,
  • A3, -A4, -A6, -A10, -A12 or New York (NY) esophageal squamous cell carcinoma-1 (ESO-1) (NY-ESO-1) (by real-time quantitative PCR (RT-qPCR))
  • Patient expressing the targeted Human Leukocyte Antigen (HLA) restriction (A0201 /A0101/ B3501)
  • 4 weeks interval following surgical resection of tumor and, if applicable, completion of adjuvant therapy.
  • Karnofsky over 70%
  • No other concomitant malignancy

Exclusion Criteria:

  • History of anaphylaxis or severe allergic reaction
  • Severe heart, lung, kidney, liver or psychiatric condition
  • Concurrent immunosuppressive therapy or impaired immune system

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    rVV-740CTA vaccine

    Arm Description

    Outcomes

    Primary Outcome Measures

    number of adverse Events
    Safety measured by assessment of number of adverse events that have occured
    number of serious adverse Events
    Safety measured by assessment of number of serious adverse Events that have occured

    Secondary Outcome Measures

    Evolution of Immune reactivity to the CTA
    Vaccine epitopes specific CD8+ T-cell responses will be evaluated from peripheral blood samples prior, during and after treatment.
    Disease free survival
    number of patients with no relapse of disease at timepoint 2 years
    Overall survival
    number of patients still living at timepoint 2 years

    Full Information

    First Posted
    May 11, 2016
    Last Updated
    February 5, 2020
    Sponsor
    University Hospital, Basel, Switzerland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03110445
    Brief Title
    Cancer/Testis Antigen Immunotherapy Phase I Study With 740-CTA Vaccinia Virus
    Acronym
    rVV-740CTA
    Official Title
    Monocentric Open Label Phase I Immunotherapy Trial of Breast Cancer Patients With a Non-replicating Recombinant Vaccinia Virus Expressing Cancer/Testis Antigens and Cluster of Differentiation Antigen 80 (CD80)-CD40L Costimulatory Molecules.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    not sufficiently staff available to perform trial
    Study Start Date
    March 2020 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    September 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Basel, Switzerland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Monocentric open-label phase I/II trial aiming at evaluating, in adjuvant setting, safety (primary outcome), immunological and clinical efficacy (secondary outcomes) of a non replicating recombinant vaccinia virus expressing cancer/testis antigen (CTA) derived epitopes and CD80 and CD40 ligand (CD40L, CD154) costimulatory molecules in patients with CTA expressing tumors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    rVV-740CTA vaccine
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    rVV-740CTA
    Intervention Description
    non replicating recombinant vaccinia virus expressing 7 Cancer Testis Antigen (CTA) epitopes together with CD80 and CD154(40L)
    Primary Outcome Measure Information:
    Title
    number of adverse Events
    Description
    Safety measured by assessment of number of adverse events that have occured
    Time Frame
    2 years
    Title
    number of serious adverse Events
    Description
    Safety measured by assessment of number of serious adverse Events that have occured
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Evolution of Immune reactivity to the CTA
    Description
    Vaccine epitopes specific CD8+ T-cell responses will be evaluated from peripheral blood samples prior, during and after treatment.
    Time Frame
    18 months
    Title
    Disease free survival
    Description
    number of patients with no relapse of disease at timepoint 2 years
    Time Frame
    2 years
    Title
    Overall survival
    Description
    number of patients still living at timepoint 2 years
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Surgically treated M0 patients with solid tumors Tumor expressing at least one of the vaccine targeted antigens Melanoma-associated antigen (MAGE)-A1, -A2, A3, -A4, -A6, -A10, -A12 or New York (NY) esophageal squamous cell carcinoma-1 (ESO-1) (NY-ESO-1) (by real-time quantitative PCR (RT-qPCR)) Patient expressing the targeted Human Leukocyte Antigen (HLA) restriction (A0201 /A0101/ B3501) 4 weeks interval following surgical resection of tumor and, if applicable, completion of adjuvant therapy. Karnofsky over 70% No other concomitant malignancy Exclusion Criteria: History of anaphylaxis or severe allergic reaction Severe heart, lung, kidney, liver or psychiatric condition Concurrent immunosuppressive therapy or impaired immune system
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul ZAJAC, PhD
    Organizational Affiliation
    University Hospital Basel - Dept of Biomedicine
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Walter WEBER, MD
    Organizational Affiliation
    University Hospital of Basel - Dept of Surgery
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    publication per reviewed journal

    Learn more about this trial

    Cancer/Testis Antigen Immunotherapy Phase I Study With 740-CTA Vaccinia Virus

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