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Brain Tumor News!


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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09/12/21 Study protocol for OptimalTTF-2: enhancing Tumor Treating Fields with skull remodeling surgery for first recurrence glioblastoma: a phase 2, multi-center, randomized, prospective, interventional trial        

 This is an exciting new trial, where they are going to try to increase the effectiveness of Optune by drilling 5 small holes through the skull over the tumor with the intention of increasing the field strength of Optune where it is needed the most.  It is a randomized trial for people with recurrent glioblastoma. Half of the patients will get the remodeling surgery and half do not. All of the patients then get Optune plus whatever their doctor thinks is best.

Note that the erticle has a typo in the clinical trial identifier. For details go to: https://clinicaltrials.gov/ct2/show/NCT04223999  (They left off the last 9 in the NCT number!)



09/11/21 A Month I Hope No Reader Must Face the Loss of A Child        

 Sept. is child cancer awareness month. This article by a friend of mine talks about the loss of her daughter, Vivienne, and ways you can help speed up the search for the cure. She mentions the Promising Pathway Act. I think getting that law passed is the #1 most important thing we can do to speed up the search for the cure. And it doesn't even cost you anything. Just go to https://virtualtrials.org/activism.cfm#/1/ and send a letter to your representatives. Only takes a few minutes. Then send it to all of your friends and family to do. We need a LOT of emails to make any difference.  If you have any political connections, talk to me about how we can use them!



09/11/21 The Importance of Shared Decision-Making for Patients with Glioblastoma        

 I am one of the authors of this paper on how the medical decision making process should be handled.



09/07/21 Lessons learned from contemporary glioblastoma randomized clinical trials through systematic review and network meta-analysis: part 2 newly diagnosed disease        

 This is an overview of the major phase 3 clinical trials for newly diagnosed Glioblastoma.    Unsurprisingly, TTF  (Tumor Treating Fields, also known as Optune) had the best results of any phase 3 trials for Glioblastoma.  The most upsetting thing is that other treatments that looked good are not only not available but have been discarded and are no longer being developed. One such treatment is ICT-107. This was a therapeutic vaccine that did amazing in some people but it failed to hit it's main endpoint on a randomized phase 2 study.  Some analysis of the trial showed that it really was a success but not as designed in the original protocol so it was deemed a failure.   As this article shows, it still did a lot better than the standard of care (this paper considers the old standard of care before Optune was added).   I am trying to get a new law passed - the Promising Pathway Act - which would let us get access to the group of treatments from this article that did better than the standards but are not available to you now.  



09/05/21 Does proton therapy have a role in the treatment of brain tumors?        

Proton radiation has a few theoretic  benefits over the standard photo or gamma radiation.  It can limit the radiation dose to the normal tissue better and should have less long term side effects. 

If a tumor is up against the optic nerve, Proton radiation can hit the tumor without hurting the optic nerve.   

The downside is most brain tumors are diffuse and you need to treat a border around the tumor anyway, and it is more expensive and harder to find a facility.

More studies need to be done to prove an advantage.   



08/28/21 #CancelChildhoodCancer citizen petition campaign.        

This is quick and easy.    We need you to sign a petition on Change.org to help speed up the search for pediatric cancers, including brain cancers! Our friends at the Pediatric Brain Tumor Foundation are spearheading this campaign! This literally took me 10 seconds to do.  



08/26/21 Researchers Discover Treatment That May Be Viable For Human Brain Cancer        

This article talks about a new treatment in dogs that have glioblastomas. A single injection helped most dogs and 1 dog had a complete remission.  Next they will be trying it in people. I wish them luck and will be keeping an eye on this!



08/25/21 Help Us Better Understand Glioblastoma Multiforme        

 This is from our friends at Pinpoint Patient Recruiting.  They do surveys and interviews to help drug companies learn about the needs of the Glioblastoma patients and caregivers.  They give us (the Musella Foundation) a donation, and you get $75 for taking the survey. Everyone wins and you help these companies understand our needs better!



08/25/21 A phase Ib/IIa trial of 9 repurposed drugs combined with temozolomide for the treatment of recurrent glioblastoma: CUSP9v3        

 This is the results of the CUSP9v3 trial, and they are impressive. It was not controlled and is relatively small, but for patients with recurrent glioblastoma, the progression free survival rate at 12 months was 50%.    This is a combination of older non cancer drugs, along with Temodar. All are easily available and relatively safe. May be worth trying both for newly diagnosed and recurrent Glioblastoma.



08/25/21 Musella Foundation Copay Program now closed to new and renewal patients        

 We had a good run but ran out of money.  We gave out 280 grants so far this year to patients, each up to $5,000 - which adds up to an amazing $1,395,000 (if they all use their entire grant - if not, we reclaim the money and recycle it for the next patients!)



08/12/21 A phase Ib/IIa trial of 9 repurposed drugs combined with temozolomide for the treatment of recurrent glioblastoma: CUSP9v3        

 This is the latest version of CUSP9   (CUSP9v3)

This is a very small study so obviously has to be repeated with larger numbers but they have impressive data. Looking at the survival curve for survival, progression free survival at 12 months was 50% which is pretty good. However, of the 5 patients who lived that long, none of them did yet, so there is a tail of the curve that doesn't drop below the 50% survival point. 

This is a for a cocktail of repurposed drugs that are easily available, in addition to Temozolomide.



08/12/21 Hackensack Meridian Children's Health Children's Cancer Institute Now a Member of the Pacific Pediatric Neuro-Oncology Consortium (PNOC)        
This is exciting news - I am a big fan of Hackensack Meridian Children's Cancer Institute as they once treated a relative of mine for a glioblastoma. And I love PNOC - they are involved with the most important trials for pediatric brain tumors.  This collaboration will bring these trials to New Jersey and upstate NY!   NYU in Manhattan is also a participating center!
See https://pnoc.us/participating-sites/ for all of the sites!
 


08/11/21 Musella Foundation Copay Assistance program is running low on funding        

funding         This program is a life saver. I started it because both of my family members who had glioblastomas also had problems with the cost of their treatments.  The program is funded by donations directed to this program and does NOT take anything away from the money we raise for brain tumor research. That is a separate fund.  When making a donation, you can tell us which fund to apply your donation to and if you want to just fund research, 100% of your donation will go to brain tumor research!  You can make donations at https://virtualtrials.org/donate



08/02/21 Amazon Smile Fundraiser! Action Required!        

 Amazon will donate a small amount to our organization every time you buy something from them!  Participating from the website is simple. Just go to smile.amazon.com instead of amazon.com. You username and password will work. Select the Musella Foundation as your charity the first time you use the Smile.amazon.com website and we will get the donations until you choose to stop it.  However, if you use the App, they require a little more work.  See instructions below on how to turn it on, but Amazon turns it off every August and February and you have to turn it back on!  

Thanks for helping!



07/30/21 Help support the Promising Pathway Act        
We have not had much progress in the treatments of Glioblastomas. Ever.  Of every phase 3 clinical trial that was ever done for Glioblastomas, only a handful were considered a success, and the best of them, the Optune EF-14 trial,  only increased median survival by 5 months.    We tried this methodology for about 70 years and it did not work. Time to try something new.
 
The current system is too rigid and slow. A trial is designed, then has to run out for 3-15 years to get a result. Then they run another trial based on those results. The cost and time are so significant that most of the promising treatments in the lab never get into human trials.
 
This proposal will turn the system upside down. It would minimize phase 3 trials.  Once a treatment is tested in a small group of patients and considered safe (compared to other approved treatments) and has a biologic effect, it can get a conditional approval.  All patients who use the drugs approved under this pathway have to go through an informed consent process as if they are going into a clinical trial and be made aware of the risks of using a drug not fully approved. They all have to be tracked in a virtual trial so we can learn from every patient's experience. The net results is way more research than the traditional pathway - as only about 10% of less of adult Glioblastoma participate in clinical trials.  Instead of each iteration of a new combinations taking 3-15 years and millions of dollars to test, multiple Virtual Trials of combinations can be run  at the same time, and can take a year or less and virtually no cost to the researchers and clinicians who create these cocktails.
 
These researchers and clinicians will have access to the live data so they can see which drugs and combinations have been used, how safe they were, how effective they were, and what combinations were used and how they worked out. They can propose a virtual trial of any number of combinations, and limit those to patients with specific markers.  Bad drugs will be weeded out quickly instead of lingering for decades as they do now.
 
And finally, prices should be kept under control. The payment part of the bill is still being hammered out but as it stands now, insurance should pay for the drugs.  At first that may increase costs as a lot of new drugs come out and they are used in combinations, but over time, the cost of developing drugs will plummet as will the time needed to do so, which should drop prices. Then the free market system should prevail, with many treatments with similiar results competing based on prices.  Furthermore, nonprofits like the Musella Foundation will create drugs ourselves, as nonprofits, at a reasonable price with proceeds going to the next generation of drug.  We know of many candidate drugs that did great in the lab but never made it to human trials. We could create an assembly line of pre-clinical testing and phase 1 trials, and take the best of the phase 1 results and move those onto phase 2 trials and try to get those approved.  We will see progress continuously instead of now where there is a small bump up every few years.
 
Please help.  Go to https://virtualtrials.org/activism.cfm#/1/ to send letters.   Or call your legislator.  Spread the word. Everyone in your family and circle of friends can send their own letters.
Thanks
 
 


07/29/21 Radiation therapy combined with intracerebral convection-enhanced delivery of cisplatin or carboplatin for treatment of the F98 rat glioma        

 This is the publication of a brain tumor research project that we (the Musella Foundation) funded.  It has the best results ever reported for the treatment of this rat model.    This is old (published a year ago), but I am including it now because the clinical trial that resulted from it was recently published. See next article!



07/29/21 Phase I trial of intracerebral convection-enhanced delivery of carboplatin for treatment of recurrent high-grade gliomas        

 This is the results of the clinical trial of CED delivery of carboplatin for the treatment of recurrent high grade gliomas.  It is based on data from a grant we gave for a rat trial (see previous article). This was funded by our friends at Voices Against Brain Cancer.  Overall the results are not impressive. The dose was way too low but the FDA required they start so low and slowly increase it. They started at 1 ug, then upped it to 2ug, then ended with 4ug, and did not get significant side effects. In the rat study, they found the best dosage for rats was 72ug and rats are way smaller than people.  So I would like to see this repeated but with reasonable doses.



07/27/21 Brain tumour patients and COVID-19 vaccines: IBTA international survey        

 From our good friends at the IBTA!  This is for adult (18+) brain tumor patients only!



07/26/21 Tumor-Treating Fields for the treatment of glioblastoma: a systematic review and meta-analysis        

 This gives an excellent review of Optune with an explanation of how it works, how it might be combined with other treatments to improve outcomes, and basically says it should be part of the standard of care. I agree completely.  The arguments against using Optune are discussed and put into perspective. For example, the biggest argument against was that the clinical trials did not use a "placebo" device for the control group.  I agree with the authors when they say it is unethical to make a brain tumor patient shave their head and wear an uncomfortable device around without the chance of benefit.  I would not refer patients to a clinical trial using such a placebo device control.  They also argue that the Optune group used Temozolomide longer than the control group.  Duh. The progression free period was longer in the Optune group and both groups stopped Temozolomide when progression occurred.  They go on to discuss costs. It is an expensive treatment, and in Europe it might not have the cost / benefit ratio to allow the countries to pay for it but in the USA where life is valued higher, it is worth it.  The authors do not mention it but the cost of other treatments being used which had much less benefit are way higher. Bottom line: I feel Optune should be part of the standard of care for newly diagnosed Glioblastoma.  Possibly also  for recurrent Glioblastoma but only if it is combined with something else.



07/26/21 Case Report: End-Stage Recurrent Glioblastoma Treated With a New Noninvasive Non-Contact Oncomagnetic Device        

 I have to admit that when I first heard of Novocures' Tumor Treating Fields (which later became know as Optune), I was very skeptical.  I knew of old "electrical therapy" treatments that were really scams and I lumped Optune in with that.   I was convinced when I met the people who invented Optune and they showed me their preclinical data, and then when I saw the first group of patients do well. I met a few of them and some did very well.

  Now along comes another novel therapy - this one uses oscillating magnetic field (OMF) therapy applied through a helmet that patient wears for about 3 hours a day.  I wasn't so dismissive this time.  I looked at the case report (and it is only 1 patient so you can't tell much), but the tumor volume graph is impressive. It shows a massive growth rate for the 90 days before starting treatment, then with no other treatments, this device quickly caused a big reduction is tumor volume.  I would love to see a larger trial of this. It is possibly more convenient than Optune in that you do not have to shave your head, and can take weekends off.   Will be keeping an eye on this and I wish them luck.



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