Expanded Access Neoantigen Vaccine in Solid Tumors

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

Study Overview

• Status: No longer available
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Biological: Neoantigen DNA Vaccine; Device: Integrated electroporation device

• Study Type: Expanded Access
• Expanded Access Type: Treatment IND/Protocol

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 19-x005