Expanded Access Neoantigen Vaccine in Solid Tumors

Sponsor
Washington University School of Medicine (Other)
Overall Status
Temporarily not available
CT.gov ID
NCT03914872
Collaborator
(none)
1

Study Details

Study Description

Brief Summary

This is an expanded access use study. Safety data will be collected from participants.

Condition or Disease Intervention/Treatment Phase
  • Biological: Neoantigen DNA Vaccine
  • Device: Integrated electroporation device

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access Neoantigen Vaccine in Solid Tumors

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Histologically or cytologically confirmed diagnosis of a solid tumor

    • Pathology review demonstrates tumor cellularity of >30% in quantities sufficient to complete DNA and RNA library construction

    • At least 18 years of age.

    • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

    • Able to understand and willing to sign an IRB approved written informed consent document.

    Exclusion Criteria:
    • Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.

    • Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, hepatic renal, and/or other functional abnormality that would jeopardize the health and safety of the participant as determined by the investigator based on medical history, physical examination, laboratory values, and/or diagnostic studies.

    • History of syncopal or vasovagal episode as determined by medical record and history in the 12 month period prior to first vaccination administration.

    • Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds 40 mm.

    • Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.

    • Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region.

    • Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.

    • Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.

    • Pregnant and/or breastfeeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine

    Investigators

    • Principal Investigator: William E Gillanders, M.D., Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT03914872
    Other Study ID Numbers:
    • 19-x005
    First Posted:
    Apr 16, 2019
    Last Update Posted:
    May 19, 2022
    Last Verified:
    May 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 19, 2022