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NCT00450619 · ClinicalTrials.gov registry record · Phase 2
153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT00450619: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00450619 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 44 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00450619, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
Background: * No treatment is known to improve survival for prostate cancer patients who have not been helped by previous treatments with hormones and chemotherapy. * An experimental vaccine called prostate specific antigen (PSA)/TRICOM contains genes for a protein produced by prostate cancer cells called prostate-specific antigen (PSA). The vaccine can trigger the immune system to make cells that may be able to recognize and attack the cancer cells that make PSA. * Granulocyte macrophage colony stimulating factor (GM-CSF) is an approved drug that is usually given to increase a patient's white blood cell count or to stimulate the immune system. * 1Samarium-153-ethylene diamine tetramethylene phosphonate (53Sm-EDTMP) is a radioactive drug that has been approved for many years to treat advanced prostate cancer. It is given through a vein and can be targeted directly to tumors in the bone where it can relieve pain caused by bone lesions. Radiation also increases the level of certain proteins inside the tumor, making it easier for the immune system to find and kill the tumor cells. * When laboratory mice were given just vaccine, just radiation, or a combination of both, the combination was most effective in treating tumors. Objectives: -To determine if combined treatment with PSA/TRICOM vaccine and 153Sm-EDTMP radiation can delay progression of prostate cancer better than radiation alone. Eligibility: -Patients who have advanced prostate cancer that has worsened despite treatments with hormones, have two or more bone lesions related to their prostate cancer, and have had prior treatment with docetaxel chemotherapy. Design: * Patients are randomly assigned to receive radiation alone (Arm A) or radiation with vaccine and sargramostim (Arm B). * Arm A receives 153Sm-EDTMP radiation starting on study day 8 and repeated every 12 weeks. * Arm B receives a priming vaccine on study day 1 and radiation on day 8. Radiation therapy is repeated every 12 weeks. Boosting vacci
Interventions
- BIOLOGICAL Sargramostim
- RADIATION Samarium Sm 153 lexidronam pentasodium
- BIOLOGICAL Recombinant vaccinia-TRICOM vaccine
- BIOLOGICAL Recombinant fowlpox-TRICOM vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2007-02 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00450619
The ClinicalTrials.gov registry entry for NCT00450619 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Sargramostim is the first listed.
NCT00450619 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00450619 about?
NCT00450619 is a clinical study titled "153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer". Background: * No treatment is known to improve survival for prostate cancer patients who have not been helped by previous treatments with hormones and chemotherapy. * An experimental vaccine called prostate specific antigen (PSA)/TRICOM contains genes for a protein produced by prostate cancer cells...
What is the current status of trial NCT00450619?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2007-02. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00450619?
The interventions under investigation include: Sargramostim (BIOLOGICAL), Samarium Sm 153 lexidronam pentasodium (RADIATION), Recombinant vaccinia-TRICOM vaccine (BIOLOGICAL), Recombinant fowlpox-TRICOM vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00450619?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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