Delytact is an oncolytic herpes simplex virus that in a small trial showed amazing results in recurrent glioblastoma.  Japan conditionally approved it and the treatment is now available only in Japan. We have been trying to get access here in the USA but it most likely won't happen for a while.  It is an embarrassment that Japan and France (See our recent article on Onc-201 being approved in France) are so far ahead of the USA in giving approvals to drugs for serious diseases. We in the USA can not get access to the most promising treatments.  We are trying to fix that. Go to https://virtualtrials.org/activism.cfm#/1/ for details on our proposed law to fix this!

This is groundbreaking.   The Jaime Leandro Foundation for Therapeutic Cancer Vaccines created a new Personalized neoantigen vaccines and got permission from the FDA to distribute it under expanded access.  They just announced that they treated their first brain tumor patient!  If you are interested in getting the vaccine, go to their website at https://personalizedvaccines.org/

 They released data from the recurrent H3 K27M mutated diffuse midline gliomas.  This is a really bad prognostic group - amoung the worst of the worst with no effective treatment. They reported a 20% response rate with a 11.2 month duration of response.   There was only one serious adverse effect that may possibly have been related to the drug out of the 50 patients.    20% may not sound like much but it is a big step forward. Much better than 0%. And this is only the beginning.  Hopefully this is good enough to get FDA approval, then we will be able to experiment with combinations and find the right way to use the drug.  Onc-201 will be at the heart of any combinations and we should quickly be able to find ways to make it work better!

 Onc-201 is an experimental therapy for cancer - especially brain tumors - in the USA and as far as I know, is not available for sale anywhere in the world yet.    This article says that Onc-201 is now available - as in today -  in France, but they are a little vague on the mechanism.  It may be under some type of expanded access program but I am not familiar with the regulations in France.  If anyone has any more details, please join the discussion in our forum at https://forum.virtualtrials.org/forum/main-forum/1307-onc-201-in-france

 The article talks about the use of external control groups specifically for rare diseases such as Glioblastoma. and shows that the more prognostic characteristics that are controlled for the better the results.   I recently wrote about xCures' new xUTILITY program - which creates external control groups with all known prognostic characteristics accounted for!    This can be used both for single arm trials as well as randomized trials as described in the current paper!

Disclaimer: I am a founder of xCures, own stock in xCures and am a paid consultant for xCures!

 This was a study in the test tube and in rats and it showed that tumor treating fields (Optune)  has a strong effect against tumor cells.

 xUtility is a set of tools and a regulatory grade dataset of de-identified cancer patient data.  This can easily be used to create a synthetic control group for a clinical trial. This means we do not really need placebos any more!  By being able to match patient characteristics along with the biomarkers, a valid control group can be created. We could also go back and reanalyze phase 2 trials with matched synthetic controls to better see how they are doing. A major problem in the past was phase 2 trials results appeared great when compared to the median survival of all patients, then when they get into a phase 3 trial they fail.  The main cause is those patients in the phase 2 trial were not typical and would have lived longer even without the experimental treatment.  Now we can go back and create matched controls to really tell how the phase 2 trial went. This could avoid phase 3 trials that are doomed to fail - saving lives!  This is a major advance.

Disclaimer: I am proud to say that I am a paid consultant for xCures and own stock in xCures!

 This is a new treatment approach, and it looks great in the lab. Will let you know when human trials start!

 This is a very important paper that shows a large benefit for Optune in the elderly (defined in this paper as 65 years old or older)..   The headline and the abstract missed the main point.  Read the entire paper. Bottom line is that if Optune (plus Temozolomide) is used correctly, that is over 75% of the time (over 90% was used in a different article with even better results but 75% might be an easier target for the elderly patients), there is a very large benefit over Temozolomide by itself or the combination at less than 75% usage.    Look at Figure 3 and table 4. They show that for those patients who used Optune over 75% of the time, the median survival was 21.7 months, compared to Optune at less than 75% with 12.5 months.   Looking at some other numbers, At the 3 year point, there were 20 patients still alive.  2 of them were on Temozolomide alone without Optune. 7 of them also used Optune but at less than 75% compliance, and 11 used Optune over 75%.    At 3.5 years, 9 patients were still alive.  None without Optune. 3 with Optune under 75% and 7 with Optune over 75%.  At 5 years, survival was 0% in the control group and 15% in the Optune group.      Look at https://virtualtrials.org/newsarticle.cfm?item=6607 for the paper looks at all of the patients - not just elderly. It shows a major benefit for compliance rate of 90%.

    Of course it is too early to tell how well this works but I love the concept. They are trying to bypass the blood brain barrier by grafting abdominal tissue into the cavity left when removing a brain tumor.  This should allow chemotherapies to reach the tumor better.

 This is a new approach to leptomeningeal disease - which is when the cancer spreads to the lining of the brain and /or spinal cord.  This is usually a very bad sign, with an average of about 2-3 months survival after diagnosis and no effective treatments approved yet. I wish them luck!

 This shows why brain tumor patients are more likely to develop blood clots than people without brain tumors.  They do not suggest anything to prevent it but it may be worth talking to your doctor about it.  All brain tumor patients should know about blood clots. Go to https://www.cdc.gov/ncbddd/dvt/facts.html for a nice overview with symptoms and how to prevent it!  This can be life threatening so you absolutely need to know the warning siges:  Swelling, pain, tenderness and /or redness of the skin can occur in any body part but most commonly the back of the leg. Left untreated, blood clots can travel to your lungs (pulmonary embolism) - the signs of which are difficulty breathing, faster or irregular heart beat, chest pain or discomfort which gets worse with taking a deep breath or coughing, coughing up blood and very low blood pressure, lightheadedness or fainting.

If you have any of these symptoms, it is an emergency and you need to get it checked quickly. They are very treatable if caught early but can cause huge problems or even death if ignored.

 ONC-206 is a new experimental therapy, related to Onc-201.  The first clinical trial of Onc-201 just opened at UCSF for patients with newly diagnosed diffuse midline gliomas or recurrent high grade gliomas.  

 This survey is from our friends at Pinpoint Patient Recruiting.  They are trying to learn what brain tumor patients need, so they can help you better.  This is similar to the request we made last month but they changed the requirements. Now they are looking for patients diagnosed with a Glioblastoma within the last 24 months, or their caregivers.   You get $75 for doing the survey!

 This is a different way to use Avastin: superselective intra-arterial cerebral infusion (SIACI) after Blood Brain Barrier Disruption.  The "standard" way involves IV infusion every other week until progression. This new way is delivering the Avastin only where it is needed by using a catheter inserted through the groin and threaded up to the area of the tumor. They can map out which arteries feed the tumor and inject the Avastin directly into those arteries in the brain, after blood brainso the drug is delivered in very high concentration exactly where it is needed, much higher dose to the tumor than using the IV methods. And the rest of the body doesn't get exposed, or gets a very insignificant dose, so it theoretically shouldn't have the systemic side effects of Avastin.  The procedure to perform this does add a risk, but it is only 3 injections, compared to many more the standard way.  

As to results, they look promising. The abstract did not include any controls so I looked up the original Avastin trial for newly diagnosed glioblastoma https://www.nejm.org/doi/full/10.1056/nejmoa1308573  using the standard IV method, and that did have a control group. This is just a rough comparison, as the results vary widely by many factors so the numbers aren't directly comparable.

Control group:  PFS: 7.3 months  Overall Survival:  16.1 months

IV Avastin : PFS: 10.7 months  Overall Survival:  15.7 months

SIACI Avastin:  PFS: 11.5 months  Overall Survival:  23.1 months

This is a proof of concept.  I would love to see this method of delivery used with a customized set of drugs based on the molecular pathology report from the surgery. 

 The Musella Foundation gave a $30,000 grant to help jumpstart the development of this drug - OKN-007 - back in 2013.  This is your donation dollars hard at work!

  They have been running a clinical trial of the drug for newly diagnosed as well as recurrent Glioblastomas.  Early reports look interesting https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.2538  for recurrent glioblastoma, the median progression free survival was only 1.4 months but overall survival was 21 months.  There was no control group but historically, patients with recurrent glioblastoma rarely live over a year. 21 months would be outstanding.

They will soon be starting more clinical trials, for diffuse midline glioma, DIPG, high grade gliomas and others.  They just announced that they will soon open an expanded access program, even before these new trials start. May be worth considering.

 Well deserved!  Dr Monje is one of the best brain tumor doctors in the world, as well as one of the nicest people! So happy for her!

 This project lays the foundation for a new way to treat all cancers.  If successful, the methods could be used for any targets.

 I think that all patients should sign up for this service. It is free to you (and you can get a $100 gift card if you do the survey after getting the options report).  It is useful even if you do not need to make a decision immediately - the records will be in place and organized so if a recurrence happens - you are not left scrambling to find and organize everything.

1. It will help you organize your medical records.  xINFORM takes medical records as PDF files and extracts the important information into a structured format that is easy to read.  xINFORM will automatically update the records as needed (if you give your permission - otherwise you can upload the records periodically).   It then provides you with ideas for treatments. These can be clinical trials, experimental treatments, off label cocktails or standard treatments.  You can update the list of options whenever something changes. 

2. It helps your doctors - they can see at a glance the important information about your medical history, and our report helps narrow down the hundreds of possibilities to a managable few. And finally if you and your doctor decide to pursue a treatment via expanded access or under the right to try laws, our team can help with the paperwork and phone calls - saving your doctor a lot of time and aggravation!  Your doctor can get access to a different xCures program where they can manage multiple patients through the process if they like.

3. Your participation helps all other patients with a similar case. We observe what treatments you do and the outcome so we can identify treatments that are working - and those that are not working.  Every individual is different of course - but in the case of cancer - playing the odds  of trying what worked better in similar cases is better than finding an article on the internet and trusting it.

 Unfortunately we had a scheduling problem and have to cancel tomorrow’s webinar.

The webinar was going to be on Kiyatec's newly approved test called 3D Predict.  I wanted to tell our patients about the test, and we will have the webinar as soon as possible. This test is the best way to tell if Temozolomide is going to be worth using or not in your particular case. It is more accurate than MGMT testing. Of course it is not perfect, but just better than MGMT testing. It will also test other drugs and tell you which may work the best. 

It requires a tumor sample, so f you are going to have a surgery, it is worth considering asking your doctor about ordering this test. For details see http://kiyatec.com/