Provenge Followed by Docetaxel in Castration-Resistant Prostate Cancer
Status:
Withdrawn
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
Summary
This clinical study will evaluate the role of combination therapy of Provenge followed by
docetaxel for patients with metastatic castration-resistant prostate cancer (CRPC, (prostate
cancer that is resistant to medical or surgical treatments that lower testosterone). The
purpose of this study is to look at the combination therapy of Provenge followed by docetaxel
to correlate the immunological biomarkers with clinical results for therapy. Biomarkers are
genes, proteins and other molecules that affect how cancer cells grow, multiply, die and
respond to other compounds in the body. The study drugs are approved by the Food and Drug
Administration (FDA).
Treatment will be administered on an outpatient basis. Patients will receive Provenge
followed by 6 cycles of docetaxel. Provenge is an immunotherapy (vaccine made from patient's
own blood cells) that reprograms immune cells to attack cancer. A course of therapy consists
of three doses of Provenge administered at 2-week intervals. Docetaxel is an antineoplastic
(chemotherapy that affects cancer cell growth) agent. Docetaxel dose of 75 mg/m2 will be
given intravenously as a 1-hour infusion every 21 days on Day 1 for 6 cycles (21 days).
The strategy aims to determine whether cytokine production and T cell infiltration of tumor
cells could favor regression using a combination of vaccine plus chemotherapy. Tissue
endpoints will include biopsies prior to vaccine therapy and chemotherapy and at the end of
therapy. Prostate cancer tissue infiltrates will be studied for expression of CD3, CD4, CD8,
CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological endpoints will be
secondary antigen spread and various cytokine biomarkers.
Phase:
Phase 2
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston