Docetaxel Followed by Provenge in Metastatic 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Withdrawn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 docetaxel followed by
Provenge 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 docetaxel followed by Provenge
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 6 cycles of
docetaxel followed by Provenge. 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. 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.
The strategy aims to determine whether cytokine production and T cell infiltration of tumor
cells could favor regression using a combination of chemotherapy plus vaccine. Tissue
endpoints will include biopsies prior to first chemotherapy and first vaccine therapy and at
the end of each 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