Gene Therapy for the Treatment of Brain Tumors
2 other identifiers
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 1992
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 21, 1992
CompletedFirst Submitted
Initial submission to the registry
November 3, 1999
CompletedFirst Posted
Study publicly available on registry
November 4, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2010
CompletedJuly 2, 2017
April 30, 2010
17.7 years
November 3, 1999
June 30, 2017
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- No pregnant women will be entered into the study.
- Patients with HIV infection will not be accepted for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Ram Z, Culver KW, Oshiro EM, Viola JJ, DeVroom HL, Otto E, Long Z, Chiang Y, McGarrity GJ, Muul LM, Katz D, Blaese RM, Oldfield EH. Therapy of malignant brain tumors by intratumoral implantation of retroviral vector-producing cells. Nat Med. 1997 Dec;3(12):1354-61. doi: 10.1038/nm1297-1354.
PMID: 9396605BACKGROUNDOshiro EM, Viola JJ, Oldfield EH, Walbridge S, Bacher J, Frank JA, Blaese RM, Ram Z. Toxicity studies and distribution dynamics of retroviral vectors following intrathecal administration of retroviral vector-producer cells. Cancer Gene Ther. 1995 Jun;2(2):87-95.
PMID: 7621261BACKGROUNDOldfield EH, Ram Z, Chiang Y, Blaese RM. Intrathecal gene therapy for the treatment of leptomeningeal carcinomatosis. GTI 0108. A phase I/II study. Hum Gene Ther. 1995 Jan;6(1):55-85. doi: 10.1089/hum.1995.6.1-55. No abstract available.
PMID: 7703288BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
August 21, 1992
Primary Completion
April 30, 2010
Study Completion
April 30, 2010
Last Updated
July 2, 2017
Record last verified: 2010-04-30