Thema: ONYX-015 - Therapie in Deutschland möglich?
ONYX-015 - Therapie in Deutschland möglich?
Grit Vetter
14.05.2001 10:56:40
hallo !
im Netz habe ich folgenden Artikel gefunden. Hat jemand Erfahrungen mit dieser Therapie? Welcher Arzt testet dieses medikament hier im Land?
Danke!
Phase IA Trial with ONYX-015 Adenovirus for Recurrent Malignant Gliomas
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A phase I, open label, dose escalation study involving the intratumoral injection of a new anti-tumor agent called ONYX-015 is currently enrolling patients with recurrent malignant gliomas.
ONYX-015 is a genetically modified adenovirus capable of killing p53-deficient tumor cells. It is believed that about one third of high grade tumors have a defective p53 tumor suppresser gene. The role of the p53 gene is to prevent replication of abnormal DNA during the process of cell division. In normal cells, p53 detects errors in DNA and either halts the cycle of cell division or forces the cell to undergo apoptosis or "cell suicide." If p53 has mutated and becomes inactive, abnormal DNA continues to replicate. The ONYX-015, a modified adenovirus can replicate and kill p53-deficient tumor cells, but not healthy functioning p53 cells.
In this trial, patients deemed eligible will undergo a surgical craniotomy. After resection of the tumor, injections of ONYX-015 will be performed into the residual tumor margin into ten different sites. The patient will remain in the hospital for approximately five days. Periodic MRI scans will be taken as well as blood samples.
Patients should note, the primary objective of this study is to determine the safety of the virus and to find the maximum tolerated dose of ONYX-015. Possible major risks include life threatening infection of the brain, hemorrhage, hydrocephalus, enlarged fluid-filled cavities within the brain, encephalitis, swelling and/or bleeding in the tumor and surrounding brain. More minor side effects include but are not limited to fever, headaches, transient brain swelling, and increased seizures. Prospective patients should also be aware that there may be extra costs accompanying this treatment not covered by the hospital, your insurance company or sponsors (Novel Approaches to Brain Tumor Therapy (NABTT), NCI, Onyx Pharmaceuticals) of the trial.
For more information about this trial, study locations and to check your eligibility, contact the study chairman, Dr. E.A. Chiocca, Associate Professor of Neurosurgery, Massachusetts General Hospital at 617-726-3779.
im Netz habe ich folgenden Artikel gefunden. Hat jemand Erfahrungen mit dieser Therapie? Welcher Arzt testet dieses medikament hier im Land?
Danke!
Phase IA Trial with ONYX-015 Adenovirus for Recurrent Malignant Gliomas
--------------------------------------------------------------------------------
A phase I, open label, dose escalation study involving the intratumoral injection of a new anti-tumor agent called ONYX-015 is currently enrolling patients with recurrent malignant gliomas.
ONYX-015 is a genetically modified adenovirus capable of killing p53-deficient tumor cells. It is believed that about one third of high grade tumors have a defective p53 tumor suppresser gene. The role of the p53 gene is to prevent replication of abnormal DNA during the process of cell division. In normal cells, p53 detects errors in DNA and either halts the cycle of cell division or forces the cell to undergo apoptosis or "cell suicide." If p53 has mutated and becomes inactive, abnormal DNA continues to replicate. The ONYX-015, a modified adenovirus can replicate and kill p53-deficient tumor cells, but not healthy functioning p53 cells.
In this trial, patients deemed eligible will undergo a surgical craniotomy. After resection of the tumor, injections of ONYX-015 will be performed into the residual tumor margin into ten different sites. The patient will remain in the hospital for approximately five days. Periodic MRI scans will be taken as well as blood samples.
Patients should note, the primary objective of this study is to determine the safety of the virus and to find the maximum tolerated dose of ONYX-015. Possible major risks include life threatening infection of the brain, hemorrhage, hydrocephalus, enlarged fluid-filled cavities within the brain, encephalitis, swelling and/or bleeding in the tumor and surrounding brain. More minor side effects include but are not limited to fever, headaches, transient brain swelling, and increased seizures. Prospective patients should also be aware that there may be extra costs accompanying this treatment not covered by the hospital, your insurance company or sponsors (Novel Approaches to Brain Tumor Therapy (NABTT), NCI, Onyx Pharmaceuticals) of the trial.
For more information about this trial, study locations and to check your eligibility, contact the study chairman, Dr. E.A. Chiocca, Associate Professor of Neurosurgery, Massachusetts General Hospital at 617-726-3779.
Grit Vetter
