In a new milestone in the fight against DIPG, Dr. Mark Souweidane this week performed a direct infusion of a cancer-fighting drug into the brain of a young patient — for the third time. The child was the first ever to receive three infusions, all at the highest dose level in the trial.
The six–year–old, who was diagnosed with DIPG in January of this year, joined Dr. Souweidane´s clinical trial in June, when he was treated with an interstitial infusion (also called convection–enhanced delivery, or CED) of a drug intended to stop DIPG´s usual relentless progression. By delivering the drug directly into the tumor site, Dr. Souweidane avoids the difficulty of getting that drug across the defensive blood-brain barrier. (See more about the trial.) The child received a second infusion in July, and then was treated for a third time this week.
“He´s recovering beautifully,” said Dr. Souweidane of the patient. “An MRI immediately after the infusion showed excellent drug distribution in the brain stem and no unexpected findings. More importantly, he is himself. When I spoke to him the day after his treatment and asked what he wanted to be for Halloween, he told me he wanted to be Darth Sidious.”
Several children have been treated twice in the trial, but Dr. Souweidane says this child was doing very well, with no disease progression, which boded well for a third treatment. The patient’s parents were also persistent in their drive to have their child treated again.
“They´re already asking about a fourth treatment,” says Dr. Souweidane. The first phase of the trial ended this summer, when the 27th and final patient was infused for the first time, but the FDA has approved repeated treatments as an extension of the trial.
It´s too soon yet to tell whether and how the repeated infusions will affect the ultimate course of this uniformly fatal disease. But Dr. Souweidane says there’s no reason why other children who were treated already, even at the maximum dose level, can´t be treated again. He´’s energized by these latest treatments, and is already looking ahead to the future.
“Each of the three infusions contained the seventh and highest dose level tested in this trial,” says Dr. Souweidane. “The ability to tolerate three infusions in such a short time, and of the maximum dose, paves the way for one of the possible next steps in this avenue of investigation, which could be to implant an infusion system to deliver the drug without repeated surgery.”
Whatever the next steps are, Dr. Souweidane promises to be at the forefront of the research.
Read the blog of Three-Time Winner: Dr. Souweidane Extends His Fight Against DIPG, click the link belowweillcornellbrainandspine.org/in-the-news/three-time-winner-dr-souweidane-extends-his-fight-against-dipg
Lisha is a patient of Dr. Mark Souweidane at Cornell Weill Medical Center and currently enrolled in OUR trial to find a treatment and eventual cure for D.I.P.G.
On Wed, September 21st, 2016, we learned that the results from Lisha’s last MRI were stable with no growth!
Lisha is living proof that the Cristian Rivera Foundation along with Dr.Mark Souweidane and his team at Weill Cornell are making strides in finding a cure for D.I.P.G.
Please help us cure this disease by making a tax deductible donation and raising awareness about our small foundation that is doing big things in the Cancer Community.
Today, 9/13/16, would’ve marked Cristian Rivera´s 14th birthday. The Cristian Rivera honors him by raising awareness to help rid the world of D.I.P.G. Every child should have an opportunity to grow and leave their mark on the world.
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Due to the tireless efforts of Dr. Mark Souweidane and Dr. Oren Becker and their dedication to the Pediatrics Neurosurgery community, we are close to curing D.I.P.G. YOU may be the difference we need to change the world!
Dr. Mark Souweidane today treated the final patient in his Phase I clinical trial of convection-enhanced delivery (CED) for diffuse intrinsic pontine glioma (DIPG). The trial, which had enrolled 31 patients over the past four years, was designed to test the safety of CED as a means of delivering a cancer-fighting drug directly to the site of a DIPG tumor. (More about the DIPG trial.)
The trial received FDA approval in late 2011, and the first patient was treated in May 2012. (Read “Cheering for Caitlin,” a profile of the first patient.) Since then, 30 children have received infusions of a therapeutic agent called 124I-8H9, which consists of the 8H9 antibody (produced by mice and effective against many kinds of tumors) combined with the radioactive substance 124I. The dosage of the drug was increased over the course of the trial, also testing safety, but no dose-limiting side effects occurred in any patient.
The infusions, which were done at Memorial Sloan Kettering Cancer Center, were able to deliver the drug directly to the brain stem tumor and were not blocked by the body’s protective blood-brain barrier, which normally prevents chemotherapy drugs from crossing from the bloodstream into the brain in sufficient concentrations to attack a tumor. In this trial, Dr. Souweidane was able to achieve concentrations of 1,000 times or more than what can be achieved with IV chemotherapy. He was also able to design and test new ways to measure those concentrations at the tumor site and monitor how long the drug stayed in the tumor.
Dr. Souweidane and his team will spend the next several months evaluating the data and preparing the results for publication. In the meantime, researchers in the Children’s Brain Tumor Project laboratory have been working to pave the road for the next stages of the trial. Other drugs and drug combinations are being tested to determine what the best agents are to infuse, and at what dose levels. DIPG cell lines are also being grown in the lab, providing a rich source of information about how the tumor mutates over time and responds to different treatments in vitro as well as in animal models. (More about the Children’s Brain Tumor Project.)
Read the blog post written by Dr. Souweidane after he treated the final patient in the trial, click the link below www.weillcornellbrainandspine.org/dipg-new-beginning