A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
Trial Status: Closed to Accrual
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with prostate cancer.
Inclusion Criteria
- Histological or cytological diagnosis of prostate cancer
- Adequate bone marrow, kidney and liver function
- Hormone sensitive relapsing prostate cancer after definitive local therapy (biochemical relapse) OR
- Failed prior therapy with a novel hormone (e.g. enzalutamide, abiraterone) with documented progressive disease (post-novel hormone therapy CRPC)
Exclusion Criteria
- ECOG performance status greater than or equal to 2
- Concurrent immunotherapy for prostate cancer
- History of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma) and other conditions that disorganize or alter the immune system.
- History of inflammatory bowel disease.
- Current use of any implanted electronic stimulation device
- For biochemically relapsed patients, no concurrent use of ADT or orchiectomy and no known prior or current evidence of any metastatic involvement of distant organs
- For post-novel hormone patients, no concurrent treatment with a secondary hormone (e.g. enzalutamide, abiraterone), no metastasis to the liver or brain
Arizona
Tucson
Banner University Medical Center - Tucson
Status: ACTIVE
Connecticut
New Haven
Yale University
Status: ACTIVE
Maryland
Bethesda
National Institutes of Health Clinical Center
Status: ADMINISTRATIVELY_COMPLETE
Contact: Ravi A. Madan
Phone: 301-496-3493
Email:
madanr@mail.nih.gov
Michigan
Detroit
Wayne State University / Karmanos Cancer Institute
Status: WITHDRAWN
Contact: Ulka N. Vaishampayan
Phone: 313-576-9363
Email:
vaishamu@karmanos.org
New York
New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Karen Autio
Phone: 646-422-4632
Email:
autiok@mskcc.org
North Carolina
Durham
Duke University Medical Center
Status: ACTIVE
Pennsylvania
Philadelphia
Thomas Jefferson University Hospital
Status: WITHDRAWN
Contact: William Kevin Kelly
Phone: 215-955-6084
Email:
wm.kevin.kelly@jefferson.edu
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Washington
Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: CLOSED_TO_ACCRUAL
Trial Phase Phase I
Trial Type Treatment
Lead Organization
Pfizer Inc
- Primary ID B7791001
- Secondary IDs NCI-2016-00393, PRCA VBIR FIP STUDY
- Clinicaltrials.gov ID NCT02616185