Spots Global Cancer Trial Database for hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
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Trial Identification
Brief Title: hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
Official Title: A Multi-center Study of hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse Post Definitive Surgery and Standard Therapy
Study ID: NCT02960594
Study Description
Brief Summary: This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 or INO-1401 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of ten treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
University of North Carolina, Chapel Hill, North Carolina, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Contact Details
Name: Robert Vonderheide, MD, PhD
Affiliation: University of Pennsylvania
Role: PRINCIPAL_INVESTIGATOR
Name: Autumn McRee, MD
Affiliation: University of North Carolina
Role: PRINCIPAL_INVESTIGATOR
Name: Jennifer Johnson, MD
Affiliation: Thomas Jefferson University Hospitial
Role: PRINCIPAL_INVESTIGATOR
Name: Anthony Shields, MD
Affiliation: Karmanos Cancer Center (Wayne State University)
Role: PRINCIPAL_INVESTIGATOR
Name: Nathan Bahary, MD
Affiliation: University of Pittsburgh
Role: PRINCIPAL_INVESTIGATOR
Name: Ashish Chintakuntlawar, MBBS, PhD
Affiliation: Mayo Clinic, Rochester, MN
Role: PRINCIPAL_INVESTIGATOR
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