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Protocol Number:
92-N-0246
- Title:
Gene Therapy for the Treatment of Brain Tumors Using Intra-Tumoral Transduction with the Thymidine Kinase Gene and Intravenous Ganciclovir
- Number:
92-N-0246
- 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.
- Sponsoring Institute:
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National Institute of Neurological Disorders and Stroke (NINDS)
- Recruitment Detail
- Type:
No longer recruiting/follow-up only
- Gender:
Male & Female
- Referral Letter Required:
Yes
- Population Exclusion(s):
Children
- Eligibility Criteria:
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Special Instructions:
Currently Not Provided
- Keyword(s):
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Cancer
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Gene Transfer
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Recurrent Tumors
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Primary Tumors
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Metastases
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Anti-Viral Drugs
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Chemosensitization
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Brain Tumors
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Gene Therapy
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Ganciclovir
- Recruitment Keyword(s):
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None
- Condition(s):
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Brain Neoplasm
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Neoplasm Metastasis
- Investigational Drug(s):
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Cytovene (Ganciclovir Sodium)
- Investigational Device(s):
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G1TKSVNa.53 Producer Cell Line
- Interventions:
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Drug: Cytovene (Ganciclovir Sodium)
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Device: G1TKSVNa.53 Producer Cell Line
- Supporting Site:
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National Institute of Neurological Disorders and Stroke
- Contact(s):
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This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Citation(s):
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Therapy of malignant brain tumors by intratumoral implantation of retroviral vector-producing cells
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Toxicity studies and distribuion dynamics of retroviral vectors following intrathecal administration of retroviral vector-producer cells
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Intrathecal gene therapy for the treatment of leptomeningeal carcinomatosis
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009
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