Expanded Access for PSV Personalized Oncolytic Viruses (PSV)
March 4, 2019 updated by: EpicentRx, Inc.
A compassionate use, expanded access protocol for patients who have exhausted all standard therapy having progressed on chemotherapy and immunotherapy.
Study Overview
Detailed Description
Patients will receive intratumoral or subcutaneous injection of an oncolytic virus called PSV (short for Personalized Virus) every other week until the occurrence of immune related RECIST progression, intolerable toxicity, change to another anti-cancer treatment due to lack of apparent benefit, or personal choice.
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Ability to understand and sign a written informed consent form.
- Measurable or evaluable disease with least one (1) tumor that is accessible to intratumoral injection.
- Eastern Cooperative Group (ECOG) performance status is 0-3 at Screening.
Acceptable liver function at Screening, as evidenced by:
- Bilirubin ≤ 3.0 X upper limit of normal (ULN) since this patient has
- been diagnosed with Gilbert's Disease
- AST (SGOT) and ALT (SGPT) ≤ 5 X ULN.
- Serum creatinine < 3 x institution upper limit of normal.
Patient has acceptable hematologic status at Screening, as evidenced by:
- Absolute neutrophil count ≥ 1,500 cells/mm3; and
- Platelet count ≥ 70,000/mm3; and
- Hemoglobin (HGB) ≥ 8.5 g/dL.
- Medically acceptable contraception.
- Willingness to comply with all protocol procedures, evaluations and rescue measures.
Exclusion Criteria:
- Presence of a serious co-morbid medical condition, or a clinically significant laboratory finding(s) that, in the opinion of the Investigator, suggests the presence of an infectious, endocrine, and/or other inadequately treated systemic disorder.
- An active bacterial, fungal, or viral infection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Morris, MD, University of Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 7, 2022
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
May 7, 2018
First Submitted That Met QC Criteria
May 7, 2018
First Posted (Actual)
May 18, 2018
Study Record Updates
Last Update Posted (Actual)
March 6, 2019
Last Update Submitted That Met QC Criteria
March 4, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PSV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.