Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00090480 · ClinicalTrials.gov registry record · Phase 1
Vaccine Treatment for Advanced Breast Cancer
A Phase 1 study, sponsored by NewLink Genetics Corporation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT00090480 is a Phase 1 study that was terminated before completion, run by NewLink Genetics Corporation. The registered enrollment target is 3 participants.
The verdict
NCT00090480, a Phase 1 study, was terminated before completion, sponsored by NewLink Genetics Corporation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This 2-phase study will determine the safety of treating patients with breast cancer with the genetically engineered HyperAcute-Breast cancer vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed breast 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 18 years of age or older with breast 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 four vaccinations a month 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. Weekly blood samples will be drawn during the 4 months of vaccine treatment. In addition, patient follow-up visits will be scheduled every 2 months for the first year 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-B Assessment questionnaire to measure the impact of treatment on the patient's general well-being.
Interventions
- BIOLOGICAL HyperAcute - Breast cancer vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2004-08 |
| Est. Completion | 2007-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00090480
The ClinicalTrials.gov registry entry for NCT00090480 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 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 - Breast cancer vaccine is the first listed.
NCT00090480 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00090480 about?
NCT00090480 is a clinical study titled "Vaccine Treatment for Advanced Breast Cancer". This 2-phase study will determine the safety of treating patients with breast cancer with the genetically engineered HyperAcute-Breast cancer vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed breast c...
What is the current status of trial NCT00090480?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2004-08. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00090480?
The interventions under investigation include: HyperAcute - Breast cancer vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00090480?
This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.