12/05/13 Update

OVERVIEW – Tedious but MAJOR progress has been made over the last few months!  Click here to read more...

An appropriate NIR LED light array has been identified and funded; diagnostic techniques have been perfected that confirm that the photosensitive PpIX is present within the NF tumor cells; the FDA has issued an exemption from special application for use of Levulon for these clinical studies; and continued clinical studies are in process.  These important events clear the hurdles for PhotoDynamic Therapy (PDT) studies on NF dermal tumors that should be highly efficient and productive with the new light array. Pretty darn exciting!!

NIR (Near InfraRed) LIGHT ARRAY – Recall there is a need for larger light array treatment panels for efficient treatment of the dermal and subdermal NF tumors.  Panels that treat a field with multiple NF tumors in one fell swoop contrast with the prior small individual lights that treat one or a few2012-1-22 cutaneous tumors tumors at a time.  The photo shows an example of multiple tumors that can now be treated in one fell swoop with a light array.  Furthermore the prior small lights needed restarting by hand every few minutes and the intensity (brightness) is only about 14mw/cm2 vs the desired 50 mw/cm2.

Because funds are limited, there have been challenges acquiring the correct NIR LED light array panels for the treatment of dermal and sub dermal NF tumors.  The clinical team thought they i2013-8, Omnilux Professional Unitdentified a good light; and the price was right, the manufacturer donated it to the project.  However, it could not produce the required intensity.  A new light array that meets the requirements has been identified, an Omnilux Revive, see photo. The light is the desired wavelength (630 nm, a bright red), and the brightness or intensity is 105 mw/cm2.  The full intensity can be used if desired or diffused over an even larger area for lower intensities.

The Children’s Tumor Foundation (CTF) came to the rescue with a grant for $15,000 for the Omnilux light array and a Microneedle PDT Drug Application Device.  This is a significant event, because the CTF is THE national NF foundation dedicated to making life better for NF children.  The CTF is the world’s first NF organization.

Probably no one is happier with the new LED light array than Dr. Edit Olasz, MD 2014-6-24, Olasz_EditDermatology, PhD, shown on the right.  Dr. Olasz is involved where the “rubber meets the road”.  She treats the NF patients who are participating in the study. Up to now Dr. Olasz and her clinical team have had to use small LED lights that can treat only a small tumor area with each treatment; and they have had to manually restart each light every few minutes when they turn off for a cooling rest – HIGHLY HECTIC AND INEFFICIENT!   The new Omnilux light array enables treatment of much larger fields of multiple tumors in one fell swoop; and will operate continuously for a desired time.

CLINICAL RESEARCH STATUS – The photo sensitive chemical Levulan Kerastick is applied topically and is absorbed in to the dermal layer.  The Levulan converts to the photosensitive Protoporphyrin IX (PpIX).  When the PpIX is exposed to NIR light, Free Radical Oxidants are created that kill the tumor cells. The FDA has approved use of Levulan for this study.

The objective of Phase I is to assess and confirm that the PpIX does indeed end up in the tumor cells.   The last several months have been invested in developing the techniques that accurately make this assessment.  Recent fluorescence microscopy studies have confirmed the presence of PpIX in the NF tumor cells.  This is very good news that enabled the clinical team to get approval from the Institutional Review Board (IRB) to proceed with the study.

As this newsletter is being written, Dr. Olasz is beginning PDT on adult NF patients for this next round of trials.  Click here to see our study on the NIH clinical trials website.

At the maximum setting the new Omnilux light is over 7 times more intense than previous lights.   Most assuredly this significant change will require adaptations and adjustments to optimize it for treatment of the NF dermal tumors.  The Levulon PDT was developed for and is used to kill actinic keratoses cells.  Some pain is associated with this procedure.  Similarly some pain would be expected as NF tumor cells are killed.

These  initial NF studies with the new Omnilux light will explore virgin territory.  If pain occurs, testing will be needed to optimize the procedure to manage pain at a tolerable level while maintaining a desirable killing rate of tumor cells.

ULTIMATE STUDY OBJECTIVE – The dermal tumors such as shown in the above photo can occur elsewhere including the face.  The Dr. Whelan study team is working toward treating such tumors when they are very small and virtually imperceptible.   Potentially PDT will be safe even for infants and thus will lend itself to very early treatment of such tumors when they are very small.  WOULDN’T IT BE WONDERFUL TO BE ABLE SAVE CHILDREN FROM THE PAIN OF SUCH VISIBLE TUMORS?!

 INTEREST IN THE RESEARCH – NF families in the Milwaukee area are learning about the Dr.Whelan team clinical studies through local organizations like the Milwaukee chapter of the Children’s Tumor Foundation.  I understand that there are multiple people who are inquiring about volunteering for the clinical studies.

WE INVITE YOU TO JOIN THIS CHALLENGE – Each light array comprises one treatment station gathering research information from one patient.  If the Clinical team had a second treatment station, for virtually the same labor investment 2 times the data could be gathered.  If you feel motivated to donate or raise funds for a second treatment station, there is currently $5,000 or about 1/3 of the $15,000 cost available as a down payment.

If you wish to join this challenge, the donation should go to Benjamin’s NOW Fund at the Children’s Hospital of Wisconsin. Please click here  and select Benjamin’s NOW Fund from the “Gift Designation” drop down menu.  If you wish, please let me know if you donate and we can keep a progress chart.

WEBSITE – Thanks to Kendra Kawala, former intern on the clinical study, for giving us a big headstart on a website.  The blank space is filling with information bit by bit.  The website is starting to look like a real website.   Please visit  http://bensresearchfund.org .  This website will be a continuing work in progress.


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