Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer

Summary

Background: \- Sipuleucel-T is a new treatment for advanced stage prostate cancer. It takes cells from a person with prostate cancer and treats them in the laboratory. Then it returns the cells to the person to help the immune system fight the cancer. Sipuleucel-T may be combined with the drug CT-011 to boost its ability to kill cancer cells. The chemotherapy drug cyclophosphamide will also be given, either before or after the cells are collected at the start of the treatment. Objectives: \- To test the effectiveness of Sipuleucel-T, CT-011, and cyclophosphamide for prostate cancer. Eligibility: \- Men at least 18 years of age who have advanced prostate cancer. Design: * Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies. * This study has two parts, with different participants in each part. All participants will be monitored with frequent blood tests and imaging studies. * Part I: * Participants will provide cells for the Sipuleucel-T treatment three times. The first time will be 3 days before the chemotherapy. The second time will be 10 days after chemotherapy. The third time will be 24 days after chemotherapy. * Participants will have one dose of cyclophosphamide the day before the first dose of Sipuleucel-T. * Participants will have Sipuleucel-T about 3 days after each cell donation. * Part II: * Participants will be in three groups: Sipuleucel-T given alone, given with CT-011, or given with both cyclophosphamide and CT-011. * Participants will provide cells for the Sipuleucel-T treatment three times, as in Part I. * Participants will have Sipuleucel-T about 3 days after each cell donation, and will receive treatment with the other drugs as directed by the study doctors.

Timeline

Start

2012-09

Primary completion

2016-12

Completion

2016-12

Publications

• Background Jemal A, Center MM, DeSantis C, Ward EM. Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomarkers Prev. 2010 Aug;19(8):1893-907. doi: 10.1158/1055-9965.EPI-10-0437. Epub 2010 Jul 20.
• Background Gittes RF. Carcinoma of the prostate. N Engl J Med. 1991 Jan 24;324(4):236-45. doi: 10.1056/NEJM199101243240406. No abstract available.
• Background Crawford ED, Eisenberger MA, McLeod DG, Spaulding JT, Benson R, Dorr FA, Blumenstein BA, Davis MA, Goodman PJ. A controlled trial of leuprolide with and without flutamide in prostatic carcinoma. N Engl J Med. 1989 Aug 17;321(7):419-24. doi: 10.1056/NEJM198908173210702.

Drugs

Indications