|
Gene Therapy for the Treatment of Brain Tumors Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Gene Therapy for the Treatment of Brain Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Gene Therapy for the Treatment of Brain Tumors Clinical research trials and Gene Therapy for the Treatment of Brain Tumors healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Gene Therapy for the Treatment of Brain Tumors. Gene Therapy for the Treatment of Brain Tumors Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Gene Therapy for the Treatment of Brain Tumors clinical trial. Subjects frequently obtain the most expert healthcare possible for their Gene Therapy for the Treatment of Brain Tumors condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "G" Clinical Trials Conditions > Gene Therapy for the Treatment of Brain Tumors  Gene Therapy for the Treatment of Brain Tumors
Gene Therapy for the Treatment of Brain Tumors
For Condition: Brain Neoplasm,Neoplasm Metastasis
Status: No longer recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: 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.
Details: Malignant brain tumors are responsible for significant morbidity and mortality in both pediatric and adult populations. These common tumors present an enormous therapeutic challenge due to their poor outcome despite radical surgery, high dose radiotherapy and chemotherapy. Survival of patients from the time of diagnosis is measured in months and recurrence after treatment is associated with a life expectancy of weeks. In an attempt to improve this grim prognosis of patients with malignant brain tumors (both primary tumors and secondary metastasis from systemic cancer such as melanoma, lung and breast cancer), we developed a novel approach to the therapy of brain tumors. This approach makes use of recombinant DNA technology to transfer a sensitivity gene into a brain tumor. This is achieved by direct injection of the tumor with a cell line actively producing a retroviral vector carrying a gene conferring drug sensitivity to the tumor. A retroviral vector is a mouse retrovirus genetically engineered to replace its own genes with a new gene. Such vectors are capable of "infecting" mammalian cells and stably incorporate their new genetic material into the genome of the infected host. The producer cell is an NIH 3T3 cell that has been genetically engineered to continually produce retroviral vectors. The new gene is incorporated into the genome of the tumor cells and expresses the protein which is encoded by the new gene. This protein (the herpes simplex virus enzyme thymidine kinase, HS-tk) sensitizes the tumor cells to an antiviral drug (ganciclovir, GCV) which is a natural substrate for HS-tk. The enzymatic process induced by GCV leads to death of a natural substrate for HS-tk. The enzymatic process induced by GCV leads to death of the cell expressing the herpes TK activity, i.e., death of the tumor cells. Since the HS-tk enzyme which is normally present in mammalian cells has very low affinity for GCV, systemic toxicity related to this mechanism is not observed. This type of in vivo gene transfer has several unique features. First, these retroviral-vectors will only integrate and express their genes in cells which are actively synthesizing DNA. Therefore, surrounding non-proliferating normal brain tissue should not acquire the HS-tk gene and will remain insensitive to GCV. Second, all of the transduced tumor cells (and retroviral vector producing cells) will be killed by the host immune response and/or GCV treatment eliminating potential concern about insertional mutagenesis giving rise to malignant cells. This is the first clinical attempt to treat malignant tumors in human beings by in-vivo genetic manipulation of tumor's genome.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 20
Location and Contact Information:
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 920246; 92-N-0246
Study Start Date: August 21, 1992
Record last reviewed: June 25, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001328
Other Neoplasm Metastasis Studies:
1. A Pilot Study of Stereotaxic Radiosurgery for Intracranial Neoplasms
2. Evaluation of Factors in Human Brain Tumors
3. Temozolomide and O6-Benzylguanine for Treating Childhood Cancers
4. Gene Therapy for the Treatment of Brain Tumors
5. PET Scan of Brain Metabolism in Relation to Age and Disease
Related Studies:
Other Neoplasm Metastasis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Gene Therapy for the Treatment of Brain Tumors
|
|
|
|
|
|
|
|
