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NCT00788164 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy With or Without Imiquimod in Treating Patients With Grade 3 Cervical Intraepithelial Neoplasia
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT00788164 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 75 participants.
The verdict
NCT00788164, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
RATIONALE: Vaccines made from DNA or a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Applying topical imiquimod to the cervix may be an effective treatment for cervical intraepithelial neoplasia. Giving vaccine therapy together with imiquimod may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy and to see how well it works when given with or without imiquimod in treating patients with grade 3 cervical intraepithelial neoplasia.
Interventions
- DRUG imiquimod
- BIOLOGICAL pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
- BIOLOGICAL TA-HPV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2008-11 |
| Est. Completion | 2023-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00788164
The ClinicalTrials.gov registry entry for NCT00788164 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which imiquimod is the first listed.
NCT00788164 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00788164 about?
NCT00788164 is a clinical study titled "Vaccine Therapy With or Without Imiquimod in Treating Patients With Grade 3 Cervical Intraepithelial Neoplasia". RATIONALE: Vaccines made from DNA or a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Applying topical imiquimod to the cervix ...
What is the current status of trial NCT00788164?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2008-11. Estimated completion is 2023-08.
What interventions are being tested in trial NCT00788164?
The interventions under investigation include: imiquimod (DRUG), pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine (BIOLOGICAL), TA-HPV (BIOLOGICAL).
Who is sponsoring clinical trial NCT00788164?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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