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NCT01420965 · ClinicalTrials.gov registry record · Phase 2
Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer
A Phase 2 study, sponsored by Augusta University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT01420965 is a Phase 2 study that was terminated before completion, run by Augusta University. The registered enrollment target is 7 participants.
The verdict
NCT01420965, a Phase 2 study, was terminated before completion, sponsored by Augusta University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study 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.
Interventions
- DRUG Cyclophosphamide
- DRUG CT-011 (Anti-PD1 Antibody)
- OTHER Sipuleucel-T (Provenge)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2012-09 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01420965
The ClinicalTrials.gov registry entry for NCT01420965 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01420965 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01420965 about?
NCT01420965 is a clinical study titled "Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer". 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-0...
What is the current status of trial NCT01420965?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2012-09. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01420965?
The interventions under investigation include: Cyclophosphamide (DRUG), CT-011 (Anti-PD1 Antibody) (DRUG), Sipuleucel-T (Provenge) (OTHER).
Who is sponsoring clinical trial NCT01420965?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
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