Therapy of malignant brain tumors by intratumoral implantation of retroviral vector-producing cells.
Z Ram, K W Culver, E M Oshiro...
https://pubmed.ncbi.nlm.nih.gov/9396605Completed
Phase 1
Age: 19Years +
All Genders
ID00001328
Gene Therapy for the Treatment of Brain Tumors Using Intra-Tumoral Transduction With the Thymidine Kinase Gene and Intravenous Ganciclovir
Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2017-07-02
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gene Therapy for the Treatment of Brain Tumors
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
- INCLUSION CRITERIA:
All adults, greater than 18 years of age, with malignant brain tumors (primary and metastatic) who failed all standard therapy for their disease will be eligible to enter the study.
EXCLUSION CRITERIA:
No pregnant women will be entered into the study.
Patients with HIV infection will not be accepted for this study.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Toxicity studies and distribution dynamics of retroviral vectors following intrathecal administration of retroviral vector-producer cells.
E M Oshiro, J J Viola, E H Oldfield...
https://pubmed.ncbi.nlm.nih.gov/7621261Intrathecal gene therapy for the treatment of leptomeningeal carcinomatosis. GTI 0108. A phase I/II study.
E H Oldfield, Z Ram, Y Chiang...
https://pubmed.ncbi.nlm.nih.gov/7703288