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This webinar is for the people who are involved in designing brain tumor clinical trials. It is a project we are working on to speed up the search for the cure. Standardizing the brain tumor scans across all MRI machines will allow for more accuracy when comparing scans, speeding up the process and reducing costs.
Great news for brain tumor patients!
Ben Williams is a 20+ year GBM survivor and has written a book about his experiences. Every year he writes an update to keep it current. This is a must read. It outlines all of the treatment options available for Glioblastoma and other high grade gliomas.
New this year, Stephen Western, who is the medical writer for virtualtrials.com, helped Ben organize and format this free e-book. There is now a table of contents and a list of the major changes from last year.
This is a living document - you can discuss it in our braintumor treatments online support group - point out errors / omissions or if anything is not clear, and we can fix it for the next version.
Last year, Celldex announced the results of a trial for recurrent GBM where they compared thier new vaccine (Rintega) combined with Avastin against Avastin alone. At 18 months after the start of the trial (which starts at recurrence), twice as many patients were alive in the vaccine + avastin group compared to the Avastin arm. In one subgroup, called Per Protocol, it was more dramatic - the vaccine tripled survival. And best yet - there was NO additional toxicity compared to the avastin group.
This article talks about the disappointing FDA decision that these results are not good enough to qualify for approval yet. They want the company to finish a larger trial before applying for approval. The FDA says the trial is too small, which it is if you look at it objectively. Of course we would like to have more data. However, when you are talking about a disease where just 10-15 % of patients are alive 18 months after recurrence, and a simple vaccine which is injected into the arm with minimal to no side effects can double or triple those alive, it doesn't make sense not to allow patients access to this treatment.
There needs to be another pathway to approval. Perhaps a system where such treatments can be approved provisionally: patients can get them, but every patient has to be registered and followed for survival and side effects. After a predetermined number of patients use the treatment, the FDA can re-evaluate the data and if it is not favorable, remove the approval. Perhaps have a safety monitor watch ongoing data for side effects or increased death rate and pull the approval early if needed.
This recall only involves the caps - which might not be childproof.. the medication itself is not affected
There have been a lot of rumors flying around. What we now know is that the DC-Vax trial has stopped screening new patients for inclusion in the trial but will continue treating and observing the patients already enrolled. The company that makes it says it is a temporary suspension while they have to file some regulatory paperwork. Some of the financial websites have painted it as a much worse event - implying that it might be permanent.
I think that this is one of the most promising treatments in the pipeline - not only for brain cancer but possibly most types of cancer. I can not see it closing down at this point when they are so close to the finish line. Let's hope it is just a paperwork thing and will reopen soon.
This vaccine therapy trial should open soon. Looking forward to it.
Congratulations to Dr Rich! He is one of the bright stars in the brain tumor world and this grant should help speed up the search for the cure!
I love the concept of testing drugs approved for other types of cancer.
This new standard should be used for all new clinical trials, and if possible, even for brain tumor patients outside of clinical trials. It will allow for a better comparison from scan to scan by minimizing the differences between MRI scanners. Currently, you can do a scan in 1 MRI machine, and immediately do another scan in a different machine and the results could be off by as much as 20-25%. This makes it impossible to tell if you are doing better, worse or no change.
This standardization effort was the result of the Jumpstarting Brain Tumor Drug Development Coalition, which was started by the National Brain Tumor Society. The Musella Foundation, as well as ABC2 and the Society For Neuro-oncology are also participants in the coalition.
I thought about this a long time ago.. Colchicine is a drug that stops cells from dividing by stopping the cell cycle at a specific point. It would make sense that it would be useful for cancer but it is too toxic at high doses. I always thought it might be a good drug to try for brain tumors using it directly in the brain, not systemic so you don't get the systemic side effects. Perhaps combining it with something like the Optune system would work much better as more tumor cells would be in the middle of the cell cycle where Optune works the best.
Creating derivatives of it that aren't as toxic is worth trying.
We ran out of money and had to close to new patients. We awarded over $3 million in grants to patients to help them pay for their treatments!
This is a preliminary report on possible problems with getting too many MRIs with Gadolinium. Most (or all) brain tumor scans use Gadolinium. I would think that the benefit of knowing how the tumor is doing far outweighs the risk when the patient is known to have a brain tumor or has symptoms of a brain tumor. I know many people who have had over 20 scans with Gadolinium with no apparent problems related to it. However, it may have an impact on MRIs that are used to screen for brain tumors. They have to figure out what the actual risk of using the Gadolinium is compared to the risk of not finding a brain tumor before symptoms appear. That is going to be close - might tilt toward NOT doing screenings.
This is a small study - so we can't be sure the results are correct, but it seems to have minimal side effects, it can prevent seizures, and elevate mood. And it might make the Temodar and radiation work better! May be worth trying. It is readily available.
This is one of the most important articles of the year. Rindopepimut is a simple off the shelf vaccine given as an injection under the skin (not into the brain). Apparently it has minimal side effects. In this study, the early results for using it on recurrent glioblastoma shows an improvement of more than doubling the 6 month progression free survival rate and there are twice as many patients still progression free in the vaccine arm than the control arm.
This is just one of a few clinical trials testing this vaccine. All have been showing good results. Let's hope this treatment gets FDA approval quickly so all eligible patients can benefit. (You need to be EGFRvIII positive to benefit from the vaccine).
One of the common questions I hear about brain tumors is what diet should I be following. I never really was convinced that diet made much difference but we are seeing more evidence that it may. This article says that the Ketogenic diet in animal models increases survival. In humans there isn't enough information on survival yet but the diet was found to be well tolerated and let to a higher quality of life. It may be worth considering.
This article shows that adding Gliadel wafer at the time of the initial surgery for glioblastoma adds about 2 month to the progression free survival as well as to the overall survival. 2 months might now sound like a lot, but it may buy enough time for something else to work. I am surprised that they aren't used more frequently.
This article says that hyperbaric oxygen may make the tumor grow faster. There are some experiments which showed the opposite but this raises a red flag that we have to look into this treatment closer.
