Expanded Access Neoantigen Vaccine in Solid Tumors
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 |
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Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically or cytologically confirmed diagnosis of a solid tumor
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Pathology review demonstrates tumor cellularity of >30% in quantities sufficient to complete DNA and RNA library construction
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At least 18 years of age.
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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.
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Able to understand and willing to sign an IRB approved written informed consent document.
Exclusion Criteria:
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Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
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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.
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History of syncopal or vasovagal episode as determined by medical record and history in the 12 month period prior to first vaccination administration.
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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.
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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.
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Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region.
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Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
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Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
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Pregnant and/or breastfeeding.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- 19-x005