Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer
Status:
Terminated
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
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.