CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
Cytovene (Ganciclovir Sodium) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00001328
NCT00001328Phase 1Completed

Gene Therapy for the Treatment of Brain Tumors Using Intra-Tumoral Transduction With the Thymidine Kinase Gene and Intravenous Ganciclovir

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Nov 4, 1999·Updated Jul 2, 2017

In Brief

A Phase 1 clinical trial evaluating Cytovene (Ganciclovir Sodium) and G1TKSVNa.53 Producer Cell Line for Brain Neoplasm and Neoplasm Metastasis. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 4, 1999
Enrollment StartAug 21, 1992
Primary CompletionApr 30, 2010
TodayJul 2, 2026
Enrollment to primary: 17.7 yearsPosted 26.7 years ago

Interventions

Cytovene (Ganciclovir Sodium)drug

G1TKSVNa.53 Producer Cell Linedevice