Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00001328 · ClinicalTrials.gov registry record · Phase 1
Gene Therapy for the Treatment of Brain Tumors
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00001328 is a Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 15 participants.
The verdict
NCT00001328, a Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Malignant brain tumors are responsible for a significant amount of deaths in children and adults. Even with advances in surgery, radiation therapy, and chemotherapy, many patients diagnosed with a malignant brain tumor survive only months to weeks. In an attempt to improve the prognosis for these patients, researchers have developed a new approach to brain tumor therapy. This approach makes use of DNA technology to transfer genes sensitive to therapy into the cells of the tumor. Infections with the herpes simplex virus can cause cold sores in the area of the mouth. A drug called ganciclovir (Cytovene) can kill the virus. Ganciclovir is effective because the herpes virus contains a gene (Herpes-Thymidine Kinase TK gene) that is sensitive to the drug. Researchers have been able to separate this gene from the virus. Using DNA technology, researchers hope to transfer and implant the TK gene into tumor cells making them sensitive to ganciclovir. In theory, giving patients ganciclovir will kill all tumor cells that have the TK gene incorporated into them.
Interventions
- DRUG Cytovene (Ganciclovir Sodium)
- DEVICE G1TKSVNa.53 Producer Cell Line
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 1992-08-21 |
| Est. Completion | 2010-04-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001328
The ClinicalTrials.gov registry entry for NCT00001328 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cytovene (Ganciclovir Sodium) is the first listed.
NCT00001328 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001328 about?
NCT00001328 is a clinical study titled "Gene Therapy for the Treatment of Brain Tumors". Malignant brain tumors are responsible for a significant amount of deaths in children and adults. Even with advances in surgery, radiation therapy, and chemotherapy, many patients diagnosed with a malignant brain tumor survive only months to weeks. In an attempt to improve the prognosis for these p...
What is the current status of trial NCT00001328?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 1992-08-21. Estimated completion is 2010-04-30.
What interventions are being tested in trial NCT00001328?
The interventions under investigation include: Cytovene (Ganciclovir Sodium) (DRUG), G1TKSVNa.53 Producer Cell Line (DEVICE).
Who is sponsoring clinical trial NCT00001328?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 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.