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NCT00078494 · ClinicalTrials.gov registry record · Phase 1
Peptide Vaccine to Prevent Recurrence of Nasopharyngeal Cancer
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
NCT00078494 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 99 participants.
The verdict
NCT00078494, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
Study Summary
This study will examine the effectiveness and side effects of an experimental vaccine to prevent recurrence of nasopharyngeal cancer. The likelihood of this cancer returning is higher in patients whose original lesion was large, whose cancer had spread to the adjacent lymph nodes, or who had surgery for metastatic disease (cancer that spread beyond the primary site). Nasopharyngeal tumors are caused by a common virus called Epstein-Barr virus, which produces a protein called LMP-2. Vaccination with specific pieces, or peptides, of the LMP-2 protein may boost the immune system's fight against the cancer. The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which is intended to increase the immune response to the peptide. Patients 18 years of age and older whose nasopharyngeal cancer has been controlled by standard treatment with surgery, chemotherapy, or radiation therapy and who are currently free of disease may be eligible for this study. Candidates are screened with a physical examination and blood and urine tests. x-rays and other imaging studies are also done in patients who have not had these tests recently. All candidates are tested for HLA tissue type. Only patients with type HLA-A\*1101 or HLA-A\*2402 - the types on which the two vaccines in this study are based - receive vaccine therapy; others are offered standard medical treatment and observation. Participants are randomly assigned to receive injections of one of two different vaccines (LMP-2:340-349 or LMP-2:419-427) to determine which peptide may offer the best immunity. Each treatment course consists of weekly immunizations for 8 consecutive weeks. The injections are given under the skin of the thigh. After every other treatment course (about every 3 months), patients undergo a series of x-rays and scans to look for tumor. The immunizations are given at the NIH Clinical Center. Patients are monitored for 1 hour after each injection and have blood tests and a physical
Interventions
- DRUG EBV-LMP-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2004-02 |
| Est. Completion | 2006-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078494
The ClinicalTrials.gov registry entry for NCT00078494 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which EBV-LMP-2 is the first listed.
NCT00078494 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00078494 about?
NCT00078494 is a clinical study titled "Peptide Vaccine to Prevent Recurrence of Nasopharyngeal Cancer". This study will examine the effectiveness and side effects of an experimental vaccine to prevent recurrence of nasopharyngeal cancer. The likelihood of this cancer returning is higher in patients whose original lesion was large, whose cancer had spread to the adjacent lymph nodes, or who had surgery...
What is the current status of trial NCT00078494?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2004-02. Estimated completion is 2006-05.
What interventions are being tested in trial NCT00078494?
The interventions under investigation include: EBV-LMP-2 (DRUG).
Who is sponsoring clinical trial NCT00078494?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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