A Phase II Randomized Open Label Study of Sipuleucel-T vs. Sipuleucel-T and Tasquinimod in Patients With Metastatic Castrate-Resistant Prostate Cancer (CRPC)

NCT02159950 Phase 2 COMPLETED Results posted

This randomized phase II trial studies how well sipuleucel-T with or without tasquinimod works in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Tasquinimod may stop the growth of prostate cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sipuleucel-T is more effective with or without tasquinimod in treating prostate cancer.

Details

Lead sponsor	Roswell Park Cancer Institute
Phase	Phase 2
Status	COMPLETED
Enrolment	2
Start date	2015-01

Conditions

• Hormone-Resistant Prostate Cancer
• Metastatic Prostate Carcinoma
• Recurrent Prostate Carcinoma
• Stage IV Prostate Cancer

Interventions

• Laboratory Biomarker Analysis
• Sipuleucel-T
• Tasquinimod

Primary outcomes

• Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024 — Baseline up to 50 weeks

Countries

United States