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NCT00105053 · ClinicalTrials.gov registry record · Phase 1
Vaccine Treatment for Hormone Refractory Prostate Cancer
A Phase 1 study, sponsored by NewLink Genetics Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT00105053 is a Phase 1 study that has completed, run by NewLink Genetics Corporation. The registered enrollment target is 8 participants.
The verdict
NCT00105053, a Phase 1 study, has completed, sponsored by NewLink Genetics Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This 2-phase study will determine the safety of treating patients with prostate cancer with the genetically engineered HyperAcute-Prostate cancer vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed prostate cancer cells containing a mouse gene that causes the production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response to the foreign substance will stimulate the immune system to attack the patient's own cancer cells that have similar proteins without this sugar pattern, causing the tumor to remain stable or shrink. Patients 19 years of age or older with hormone refractory prostate cancer that has recurred or no longer responds to standard treatment may be eligible for this study. Candidates will be screened with medical history and physical examination, blood tests, urinalysis, chest x-rays and CT scans. MRI, PET, and ultrasound scans may be obtained if needed. Participants will receive twelve vaccinations two weeks apart from each other. The vaccines will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of the study will treat successive groups of patients with increasing numbers of the vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will look for any beneficial effects of the vaccine given at the highest dose found to be safe in Phase I. Monthly blood samples will be drawn during the 6 months of vaccine treatment. In addition, patient follow-up visits will be scheduled every 2 months for the remaining first year (6 months) after vaccination and then every 3 months for the next 2 years for the following tests and procedures to evaluate treatment response and side effects: * Medical history and physical examination * Blood tests * X-rays and various scans (nuclear medicine/CT/MRI) * FACT-P Assessment questionnaire to measure the imp
Interventions
- BIOLOGICAL HyperAcute-Prostate Cancer Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2005-03 |
| Est. Completion | 2007-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00105053
The ClinicalTrials.gov registry entry for NCT00105053 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NewLink Genetics Corporation, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HyperAcute-Prostate Cancer Vaccine is the first listed.
NCT00105053 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00105053 about?
NCT00105053 is a clinical study titled "Vaccine Treatment for Hormone Refractory Prostate Cancer". This 2-phase study will determine the safety of treating patients with prostate cancer with the genetically engineered HyperAcute-Prostate cancer vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed pros...
What is the current status of trial NCT00105053?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2005-03. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00105053?
The interventions under investigation include: HyperAcute-Prostate Cancer Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00105053?
This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.
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