Diffuse Intra-Axial expansive Lesion of the Enchephalic Trunk not surgically investigated _2
7-year-old boy was diagnosed with diffused intra-axial brainstem expansive lesion. He underwent radiation therapy but his physical condition is worrisome. His relatives ask the expert's opinion about experimental therapy consists of combination Antineoplaston and radiation therapy for the treatment of gliomas in children, that is now in clinical trial. The expert doesn't recommend it.
- I have seen, and have in my custody, a copy of the January 2009 press release from the X Research Institute, announcing the formation of a multi-site phase III trial to test antineoplastons A10 and AS2-1 plus radiation versus radiation alone in the treatment of newly diagnosed, diffuse intrinsic pontine glioma. Indeed, Stanford University has been invited to participate, and our group is debating this offer—we were invited 30 January.
- Patient would not be eligible for this trial, as the study is for children newly diagnosed with pontine glioma.
- Yes, the X Clinic is still and has been controversial, featured on United States newscasts, and has during the 1990s come under close scrutiny by the United States Food and Drug Administration for accusations of overstated successes of antineoplastons in cancer.
- To date, there is no peer-reviewed, solid, published or medically accepted evidence that these substances improve outcomes from brain tumors, including pontine gliomas.
- Yes, many practitioners in the United States are highly critical of the Clinic and antineoplastons, as good evidence has been lacking, despite multiple word or mouth stories and internet testimonials. Doctors have witnessed notable side-effects arising from the high use of steroids (dexamethasone) employed in conjunction with the antineoplastons. In addition, many United States physicians are further skeptical because of the high monthly price paid for this as yet unproved treatment, generally $10,000 to $15,000 a month.
- I have contacted just today 5 colleagues at leading United States Centers, like Stanford, to see their response to any invitation to participate in the phase III trial. Their response has been flat out no, to very muted enthusiasm to test this treatment rigorously once and for all (with the anticipation that no effect will be seen), to simply uncertain.
- Overall, there is no doubt that the condition of Patient is fragile and his future uncertain, worrisome, with very limited treatment options. However, almost all oncologists in the United States would not endorse antineoplastons, though it will be interesting to see how many centers will entertain this study and try to see if this treatment has any effect. Almost everyone would agree that the treatment is not curative.