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Note: The comments under each article title are the opinion of our president, Al Musella, DPM, and do not reflect official policy of the Musella Foundation!

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04/02/20 Phase I/II Clinical Study of ONC201 Begins in Japan        

 We are supporting their USA program!  This is an experimental treatment for Brain tumors with the H3K27M mutation, such as Diffuse Midline Glioma, and DIPG.




04/02/20 Initial experience with scalp sparing radiation with concurrent temozolomide and tumor treatment fields (SPARE) for patients with newly diagnosed glioblastoma.        

 This shows that using Optune during radiation is safe. They were able to complete radiation on all 10 patients without removing the arrays.  Early results look promising but too small of a study and too early to tell how well it works.




03/31/20 UF brain tumor researcher embarks on first-in-human clinical trial of novel immunotherapy vaccine        

 Interesting new approach.. Works on dogs.. hopefully it will work on people!

 




03/30/20 Musella Foundation Webinar Series        

 These webinars will start this Sunday and we have a great lineup and will be adding more topics!  The first event is a must see. There are some issues around the use of chemotherapy and steroids for patients who are exposed to the Covid-19 virus.




03/30/20 Beat19.org        

 This is from our friends at Cancer Commons and xCures..  they are running a virtual trial of the Covid-19 virus.  They do not tell you what treatments to do (yet), but will gather information on how the virus affects you, which treatments you decide to do and the outcome. By working together on this, we will get the answers we need quickly. The current research is all over the place - hundreds of small studies that are not centrally gathered and analyzed.  This study will cover all of the treatments and quickly let us see what helps the most.  This study is IRB approved and listed on clinicaltrials.gov, and is run by a group of experts.

My interest in this project is to see the effects on brain tumor patients.   See if they are more or less likely to catch it, based on the chemotherapies and steroids they are taking. And to see how they do.  Nobody has studied this yet and we need to know. 

There is absolutely no cost to participate. Signing up is easy. Then there is a daily survey where you tell them about any changes in your status or medicines and how you are feeling.  You can let your entire family sign up. They want people who are not sick as well as those already sick. 

 




03/28/20 Stimulus plan: Changes to charitable contributions!        
The new stimulus bill recognized that charities will have a hard time this year, so they gave an incentive to make donations.  See attached article for details.
 
I know this is a hard time for everyone to make donations – as always – you need to take care of yourself and your family first of course. So do not feel bad if you cannot make a donation now.   But if you are not having financial problems now, please consider giving a donation to the Musella Foundation.   This has been a bad year as far as donations go - and we have a few urgent projects that really need to be funded.   If interested, call us to discuss at 888-295-4740.
 



03/28/20 12 medical centers form brain tumor research collaborative        

 There is a new research collaborative - hopefully this will speed up the research!




03/20/20 Young girl with incurable tumour may not receive lifeline treatment in New York        
This is a horror story  that I am hearing over and over every day.  The charity mentioned should be working on bringing the treatment to the UK so that families do not have to go through the stress or embarrassment of raining money and the hassle of traveling across the ocean to be able to get treatments for their kids.    It would cost way less for the trial to be started in Europe than for all of these kids paying so much for the expenses to come to the USA. The huge costs mentioned in the article are NOT for the drug..  The drug in the clinical trial is supplied for free. The money is for the associated costs of travel, lodging, doctors visits, MRIs, blood tests and possible hospital costs.
 
And now these kids can not even fly to the USA if they wanted to (and were healthy enough to and could raise the money), due to the pandemic.  Absolute nightmare.   This should have been addressed last year. At this point, with the Coronavirus, it is difficult to raise the donations needed to fix the problem, so it probably won't happen until after the pandemic is over.  Meanwhile, these kids are dying and do not have the time to wait.    Our organization tried to raise the money to do it but were unable to.  If anyone has any leads on where we can raise significant amounts of money, let me know.  It is urgent now.
 



03/20/20 German Federal Joint Committee Updates Medical Care Directive to include Tumor Treating Fields, establishing National Reimbursement for Optune in Germany        

 Germany finally approved Optune under their national health system. 

I thought the USA was slow - Medicare approved it last year - about 4 years after it was approved for newly diagnosed glioblastoma.

It is troubling that there is such a delay between FDA approval and insurance payment approval. The same thing happened with Temodar and Avastin. In the USA, the Medicare approval process should start at the same time as the application to the FDA so the FDA and Medicare approvals come out at the same time.




03/19/20 5-Aminolevulinic Acid and Contrast-Enhanced Ultrasound: The Combination of the Two Techniques to Optimize the Extent of Resection in Glioblastoma Surgery        

 The more tumor that can be removed safely, the better the patient will do for a longer time.  The combination of 5-ala and ultrasound works better than either alone or not using any aide.  




03/16/20 Rindopepimut With Bevacizumab for Patients With Relapsed EGFRvIII-Expressing Glioblastoma (ReACT): Results of a Double-Blind Randomized Phase II Trial        

This is a difficult study to interpret.   There have been many trials of this vaccine. The early trials looked fantastic and this one looks pretty good.  However, the largest randomized phase 3  "ACT 4" trial showed no improvement in overall survival.  My thoughts are that the vaccine helps some people, with minimal side effects.  Not enough to be used by itself but might be part of the ultimate cocktail.  Treatments like this would be perfect candidates for the conditional approval pathway we are working on.




03/16/20 Researchers Uncover Racial Disparities in Brain Cancer Outcomes        

 

 Kids with brain tumors have enough problems without having to worry about discrimination. There is no place for this and it should be investigated.  I first thought it might be related to insurance or poverty but the article said even if the patient has the same insurance  they get treated differently based on skin color. Totally unacceptable.

 




03/14/20 Intraoperative MRI versus 5-ALA in high-grade glioma resection: a network meta-analysis        

 This article compares using intraoperative MRI to Gleolan (5-ALA) as to the abilty to maximize extent of resection, overall survival and progression free survival. 

 Intraoperative MRI is just what it sounds like - a machine that is able to do an MRI right in the operating room while you are having a surgery.  It is important because when they use navigation systems they use the scans to see where they are on the brain.  After they remove most of the tumor, the brain shifts a little, so the pre-op scan is no longer accurate.  They can compensate for that by doing another scan while you are in surgery, and it also can see large areas of remaining tumor. 

 Gleolan is an fda approved dye, taken orally before surgery. During the surgery, when viewed under a special light, any remaining tumor glows and the surgeon can see what needs to be removed.

The study finds that both of these significantly improve survival and all of the other endpoints.  It is not clear which one is better, with a hint that the intraoperative MRI is slightly better.  I do not see why they can't use both and make it even better.  Most hospitals do not have an intraoperative MRI.  Any hospital can use Gleolan - a special attachment to an operating microscope is required but the cost is nothing compared to the cost of an MRI machine.




03/14/20 First-line Bevacizumab Contributes to Survival Improvement in Glioblastoma Patients Complementary to Temozolomide        

 This is a controversial area.  Some prior studies on GBM said there was an improvement in progression free survival with Bevacizumab (Avastin) but no improvement in overall survival.  This study says there is an improvement with adding Avastin to the standard Temodar, and that benefit persists even if the MGMT is unmethylated.  This opens another option for unmethylated MGMT patients.  However, I would like to see more data as there are too many conflicting reports.




03/14/20 Commentary: Lomustine-temozolomide combination therapy versus standard temozolomide therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter (CeTeG/NOA-09): a randomised, open-label, phase 3 trial        

 Interesting read.    There was a trial reported last year that adding Lomustine to the standard therapy for newly diagnosed MGMT methylated GBM patients significantly increased the overal survival rate, from 31.4 months to 48.1 months.   This article talks about all fo the possible problems with the original article.  Not sure what to make of this - let's discuss it in our forum. 




03/14/20 Ketogenic Diets as an Adjuvant Therapy for Glioblastoma (KEATING): A Randomized, Mixed Methods, Feasibility Study        

 They found that most people couldn't stay on the diet for 3 months so the outcome data is meaningless.  There are various forms of the keto diet. They tried 2 different forms and both were not patient friendly.  Perhaps other versions of the diet would be easier to stay on.




03/14/20 Tamoxifen Is a Candidate First-In-Class Inhibitor of Acid Ceramidase That Reduces Amitotic Division in Polyploid Giant Cancer cells-Unrecognized Players in Tumorigenesis        

 Tamoxifen is an old drug approved for breast cancer. Many years ago, it was tried for glioblastoma. See https://virtualtrials.com/Tam1.cfm That was in the time before Temozolomide was available. Results were promising, but the results for Temozolomide were better so Tamoxifen lost favor.

This article shows a different way it may work, and it may have a role in the ultimate treatment cocktail.  By itself, it is obviously not good enough but if this article is correct, it might help other treatments work.

One idea I had is that a possible escape mechanism for Optune is tumor cells getting larger. Tamoxifen might stop the giant cells from forming.

This is a perfect use of our virtual trial system - to track how these additional drugs can help the standard treatments.  We need more people to participate.  Virtualtrials.com/brain

I had a relative who was diagnosed with a GBM in 1992 and she did well with Tamoxifen for about 5 years, which was amazing back then.

 




03/13/20 Optune Open Houses are now availble as webinars!        

 Due to the coronovirus, it probably isn't a great time to put a lot of people close together in a room, so Novocure's next few Open Houses will be online only! 

 




03/12/20 Preclinical Data Show Tumor Treating Fields Induces Immunogenic Cell Death Resulting in Enhanced Antitumor Efficacy When Combined with Anti-PD-1 Therapy        

 

       This was in animals so we do not know if it will work in people but it makes a lot of sense. The anti-PD-1 therapy (also known as checkpoint inhibitors) work to release the brakes on the immune response. So if your body reacts a little to the tumor, these checkpoint inhibitors build up on that and helps your immune system work stronger.   Given by themselves, there is a small chance of checkpoint inhibitors working on the brain tumor because most people do not mount a big immune response to their tumor.  What is needed is a way to prime the immune system, so your body mounts an attack, then the checkpoint inhibitors can enhance the immune attack.

 

   One way to do that is to break apart the tumor cells, which exposes parts of the tumor (neo-antigens) that the immune system usually doesn't see.   This sets the immune response in motion.     Optune has been shown to break apart tumor cells, so it might be the perfect complement to checkpoint inhibitors.    We can look for hints at how well it works by having all people who try the combination be monitored in our registry. Go to virtualtrials.com/ask to join our registry.




03/10/20 An innovative drug trial for brain cancer begins at UAB        

 This is an exciting new therapy.  This trial needs you to sign up before the first surgery, so if you live in the Birmingham, Alabama area and were recently diagnosed with a brain tumor, it may be worth asking about this trial.  UAB has become a leader in the brain tumor world - so it is an excellent place to be treated.

 




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