Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer
Stopped early · Phase 2
Conditions studied: Prostatic Neoplasms
In brief
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.
Key facts
- Study ID
- NCT01420965
- Run by
- Augusta University
- People needed
- 7
- Starts
- 2012-09-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2019-07-10
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may not qualify if…
- Concurrent treatment with any other cancer therapies including radiation (except palliative radiation therapy for bone metastases), chemotherapy or other investigational agent(s). Androgen suppression therapy will be allowed.
- History of a second active malignancy in the last 2 years other than non-melanoma skin cancers.
- Patients who have active or history of autoimmune disease/symptom/conditions including: type I diabetes, rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis. Type II diabetes mellitus, vitiligo or stable hypothyroidism are not considered exclusion criteria.
- Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH).
- Concurrent use of systemic glucocorticoids within 4 weeks prior to trial entry
- Patients who have acquired, hereditary, or congenital immunodeficiencies including cellular immunodeficiencies, hypogammaglobulinemia and dysgammaglobulinemia.
- CNS, lung, or liver metastasis, because of the poor prognosis, and potential inability to meet study endpoints.
- Serious active infection at the time of pre-study screening.
- Positive HIV or Hepatitis C antibodies or Hepatitis B anti-core antibodies, because immunotherapies rely on intact immune systems, and toxicities may be exacerbated by the presence of infection.
Where it is running
- Georgia Regents University — Augusta, Georgia, United States
Full record on ClinicalTrials.gov
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