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NCT00841399 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Node-Positive Breast Cancer Patients
A Phase 1 study, sponsored by COL George Peoples, MD, FACS.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT00841399: Completed Phase 1 study, sponsored by COL George Peoples, MD, FACS.
NCT00841399 is a Phase 1 study that has completed, run by COL George Peoples, MD, FACS. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00841399, a Phase 1 study, has completed, sponsored by COL George Peoples, MD, FACS.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
The purposes of this study are the following: 1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75) 2. To determine maximum tolerated dose (MTD) and optimal biologic dose (OBD) for the peptide vaccine 3. To evaluate the in vivo cellular immune response to the peptide vaccine 4. To evaluate time to recurrence in the vaccinated patients vs. matched controls
Interventions
- BIOLOGICAL E75 + GM-CSF vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2001-07 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00841399
The ClinicalTrials.gov registry entry for NCT00841399 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is COL George Peoples, MD, FACS, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which E75 + GM-CSF vaccine is the first listed.
NCT00841399 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00841399 about?
NCT00841399 is a clinical study titled "Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Node-Positive Breast Cancer Patients". The purposes of this study are the following: 1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75) 2. To determine maximum tolerated dose (MTD) and optimal biologic dose (OBD) for the peptide vaccine 3. To evaluate the in vivo cellular immune response to the pep...
What is the current status of trial NCT00841399?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2001-07. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00841399?
The interventions under investigation include: E75 + GM-CSF vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00841399?
This trial is sponsored by COL George Peoples, MD, FACS, which has 4 total clinical trials registered on ClinicalTrials.gov.
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