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NCT00001827 · ClinicalTrials.gov registry record · Phase 2
p53 Vaccine for Ovarian Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT00001827: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00001827 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001827, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
This study will examine whether vaccination with a p53 peptide can boost an immune response to ovarian cancer and what the side effects are of the vaccine. Many patients with ovarian cancer have an altered (mutated) gene called p53 that causes the production of abnormal proteins found in their tumor cells. The body s immune system may try, unsuccessfully, to fight these abnormal proteins. In this study, ovarian cancer patients with a p53 abnormality will be vaccinated with a p53 peptide a part of the same abnormal protein found in their tumor to try to boost their body s immune response to the cancer. Patients will be divided into two groups. Group A will have four p53 peptide vaccinations three weeks apart, injected under the skin. The injection will include a drug called ISA-51, which increases the effect of the vaccine. This group will also receive two other drugs that boost the immune system, IL-2 and GM-CSF. Group B will have four p53 peptide vaccinations three weeks apart. The peptide will be mixed with the patient s own blood cells and infused into a vein. This group will also receive IL-2, but not GM-CSF. All study candidates will be tested to see if their cancer has a p53 abnormality and if their immune system mounted a defense against it. These tests may include a tumor biopsy (removal of a small part of the tumor for microscopic examination); lymphapheresis (a procedure to take blood, remove white blood cells called lymphocytes, and return the red cells); and an immune response test similar to a skin test for tuberculosis. During the study, patients will have additional skin tests and blood tests.
Interventions
- BIOLOGICAL aldesleukin
- BIOLOGICAL sargramostim
- BIOLOGICAL incomplete Freund's adjuvant
- BIOLOGICAL therapeutic autologous dendritic cells
- BIOLOGICAL p53 peptide vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 1999-07-26 |
| Est. Completion | 2013-01-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001827
The ClinicalTrials.gov registry entry for NCT00001827 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 21 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 5 interventions - of which aldesleukin is the first listed.
NCT00001827 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001827 about?
NCT00001827 is a clinical study titled "p53 Vaccine for Ovarian Cancer". This study will examine whether vaccination with a p53 peptide can boost an immune response to ovarian cancer and what the side effects are of the vaccine. Many patients with ovarian cancer have an altered (mutated) gene called p53 that causes the production of abnormal proteins found in their tumo...
What is the current status of trial NCT00001827?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 1999-07-26. Estimated completion is 2013-01-25.
What interventions are being tested in trial NCT00001827?
The interventions under investigation include: aldesleukin (BIOLOGICAL), sargramostim (BIOLOGICAL), incomplete Freund's adjuvant (BIOLOGICAL), therapeutic autologous dendritic cells (BIOLOGICAL), p53 peptide vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00001827?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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