TGen Receives Approval for Patient Enrollment in Brain Cancer Clinical Trial

Catherine Ivy and Dr. David Craig

 

Glioblastoma (GBM) Pilot Trial funded by Ivy Foundation

In 2012, The Ben & Catherine Ivy Foundation awarded $10 million in grants for two groundbreaking brain cancer research projects at the Translational Genomics Research Institute (TGen). One of those projects has officially received the final regulatory approval from University of California, San Francisco, which means patient enrollment for the trial can begin.

 

In the $5-million-project, “Genomics Enabled Medicine in Glioblastoma Trial,” TGen and its clinical partners will lead first-in-patient clinical trial studies that will test promising new drugs that might extend the survival of GBM patients. This multi-part study will take place in clinics across the country and TGen laboratories.

 

“GBM is one of the top three fastest-killing cancers out there and it affects people of all ages,” said Catherine (Bracken) Ivy, founder and president of The Ben & Catherine Ivy Foundation. “It is critical that we fund research that will help patients live longer so we can study and treat brain cancer.”

 

The project begins with a pilot study of 15 patients, using whole genome sequencing to study their tumor samples to help physicians determine what drugs might be most beneficial.

 

To support molecularly informed clinical decisions, TGen labs also will examine genomic data from at least 536 past cases of glioblastoma, as well as tumor samples from new cases, developing tools that will produce more insight into how glioblastoma tumors grow and survive. TGen also will conduct a series of pioneering lab tests to measure cell-by-cell responses to various drugs.

 

“GBM is a disease that needs answers now, and we strongly believe those answers will be found in the genome,” said Dr. David Craig, TGen’s Deputy Director of Bioinformatics, Director of TGen’s Neurogenomics Division, and one of the projects principal investigators. “Identifying the genes that contribute to the survival of glioblastoma will provide valuable information on how to treat it, and may also lead to an improved understanding of what drives other cancers as well.”

 

To get new treatments to patients as quickly as possible, this five-year study will include a feasibility study involving up to 30 patients, followed by Phase II clinical trials with as many as 70 patients. TGen is teaming with the Ivy Early Phase Clinical Trials Consortium that includes: University of California, San Francisco; University of California, Los Angeles; the MD Anderson Cancer Center; Memorial Sloan Kettering Cancer Center; University of Utah; and the Dana-Farber/Harvard Cancer Center.

 

The results of these clinical trials should not only help the patients who join them, but also provide the data needed for FDA approval and availability of new drugs that could benefit tens of thousands of brain cancer patients in the future.

 

“Working with physicians, the project will aim to understand treatment in the context of the tumor’s molecular profile. We will have the opportunity to determine when combinations of drugs might be more effective than using a single drug, quickly identify which therapies don’t work, and accelerate discovery of ones that might prove promising for future development,” said Dr. John Carpten, TGen’s Deputy Director of Basic Science, Director of TGen’s Integrated Cancer Genomics Division, and another of the project’s principal investigators.

 

In addition to helping patients as quickly as possible, the project should significantly expand Arizona’s network of brain cancer experts.

 

About The Ben & Catherine Ivy Foundation

The Ben & Catherine Ivy Foundation, based in Scottsdale, Ariz., was formed in 2005, when Ben Ivy lost his battle with glioblastoma multiforme (GBM).  Since then, the Foundation has contributed more than $50 million to research in gliomas within the United States and Canada, with the goal of better diagnostics and treatments that offer long-term survival and a high quality of life for patients with brain tumors.  The Ben & Catherine Ivy Foundation is the largest privately funded foundation of its kind in the United States.  For more information, visit http://www.ivyfoundation.org. We have regular updates via social media – please find us on:

Blog:  Ivy Foundation http://www.IvyFoundation.wordpress.com

Facebook:  Ivy Foundation  http://www.facebook.com/IvyFoundation

Twitter:  @IvyFoundation https://twitter.com/IvyFoundation

Google+:   Ivy Foundation https://plus.google.com/105982076267406579679/posts

LinkedIn:  Ivy Foundation http://linkedin.com/company/the-ben-and-catherine-ivy-foundation

YouTube:  IvyFoundationGBM http://www.youtube.com/user/IvyFoundationGBM

 

About TGen

The Translational Genomics Research Institute (TGen) is a Phoenix-based non-profit organization dedicated to conducting groundbreaking research with life changing results. Research at TGen is focused on helping patients with diseases such as cancer, neurological disorders and diabetes. TGen is on the cutting edge of translational research where investigators are able to unravel the genetic components of common and complex diseases. Working with collaborators in the scientific and medical communities, TGen believes it can make a substantial contribution to the efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org.

Learn About Brain Cancer

Brain Cancer

A disease of the brain in which cancer cells (malignant) arise in the brain tissue. Cancer cells grow to form a mass of cancer tissue (tumor) that interferes with brain functions such as muscle control, sensation, memory, and other normal body functions.

Brain Tumor

An abnormal growth of tissue in the brain.  Unlike other tumors, brain tumors spread by local extension and rarely metastasize (spread) outside the brain.

Clinical Trials

Research studies done to determine whether new drugs, treatments, or vaccines are safe and effective.  They are conducted in three phases:

  • Phase I
    In this phase, small groups of people are treated with a certain dose of a new agent that has been extensively studied in the laboratory. During the trial, the dose is increased group by group to find the highest dose that does not cause harmful side effects. Usually there is no control treatment for comparison. This process determines a safe, appropriate dose for use in Phase II.
  • Phase II
    This phase provides continued safety testing of a new agent, along with an evaluation of how well it works against a specific type of cancer. The new agent is given to groups of people and is usually compared with a standard treatment.
  • Phase III
    This phase answers research questions across the disease continuum and includes large numbers of participants so that the differences in effectiveness of the new agent can be evaluated. If the results of this phase merit further use of the new agent, the pharmaceutical company will usually submit a New Drug Application to the FDA.

Diagnostics

The determination of the nature of a disease or ailment.  A clinical diagnosis is based on the medical history and physical examination of the patient.

Glial Cells

Cells that provide structure to the central nervous system and insulate and protect neurons (cells that transmit electrical impulses that allow seeing/hearing/smelling/tasting).

Glioma

The term used to refer to the most prevalent primary brain tumors.  Gliomas arise from glial tissue, which supports and nourishes cells that send messages from the brain to other parts of the body.

Glioblastoma

Also known as glioblastoma multiforme, this is the most common and aggressive malignant primary brain tumor in humans, involving glial cells and accounting for 52 percent of all functional tissue brain tumor cases and 20 percent of all intracranial tumors.

GBM

GBM is an abbreviation for glioblastoma multiforme.

Translational Genomics

Innovative advances arising from the Human Genome Project, applying them to the development of diagnostics, prognostics and therapies for cancer, neurological disorders, diabetes and other complex diseases

Such a Beautiful Story

200 Friends Throw Early Prom to Surprise Teen Diagnosed with Brain Cancer

By KELLI BENDER

200 Friends Surprise Teen Diagnosed with Brain Cancer with Early Prom

Cancer has taken a toll on Amber Martin, but the teen’s friends made sure it didn’t take away her prom.

Martin had been looking forward to the cherished high school event since she met her boyfriend Austin Hunt in the summer of 2013. The 16-year-old even moved from her home in Lancaster, Penn., to attend high school with Hunt in Kansasa, Okla., according to Lancaster Online.

Shortly after the move and six years after Martin’s first bout with cancer, the teen’s astrocytoma, a type of brain cancer, came out of remission. The discovery rattled Martin’s new life, especially after losing her father to cancer three years earlier. She returned home for treatment and gave up on the prom she’d been anticipating for months.

“Amber wanted to attend the prom with her new boyfriend, Austin, but unfortunately, her cancer is terminal, so that’s not possible,” said her mother, Angela Hurst, to Lancaster Online. “So we made her wish known to some friends. We were hoping to do this very small and intimate, but with everyone getting involved and the donations we’ve gotten, it has turned into the night of her dreams.”

The initially small group of prom planners grew into a 200 person party committee dedicated to giving this cancer-stricken high schooler her simple wish.

Read more: http://www.people.com/people/article/0,,20782901,00.html

Community Support is Everything

Outpouring of support for young W.Va. man battling brain cancer

Elaine Blaisdell

OAKLAND — The outpouring of emotional and monetary support from the community for 20-year-old Dylan Jones, who has been battling stage 4 glioblastoma brain cancer, has been tremendous, according to his mother Erika Graham of Oakland.

“I have been floored by the response from the community,” Graham said. “The support from Garrett County alone has been tremendous, every business has posted signs asking for prayer for him. I’ve been amazed by the support of the community, it has been really great. People all over the United States have said they are praying.”

Jones, described by others as a guy who would do anything for anybody, was diagnosed with glioblastoma in December 2012. He underwent surgery at Ruby Memorial Hospital in Morgantown, W.Va., a year ago, then underwent chemotherapy and radiation at Preston Robert Tisch Brain Tumor Center at Duke University in Durham, N.C.

While receiving treatment at Duke, Jones’ insurance coverage was exhausted and costs weren’t covered, Graham said. In October, Jones was doing great and there was no sign of the cancer, according to his mother, but around Thanksgiving he started feeling tingling and numbness on his right side. Following an MRI, it was confirmed that the brain tumor had returned and that cancer cells had spread to other areas of the brain.

“The doctors decided to change his chemotherapy and medicine to try to shrink the tumor but his body didn’t respond to any of the treatments,” said Graham. “He got home last Tuesday and we decided we have exhausted all treatment options. We are now doing alternative treatments now. We are praying and hoping for the best.”

Numerous fundraisers have been held in both Oakland and Keyser, W.Va., to help with medical expenses. Money from fundraisers currently being held will go toward the holistic treatments Jones is undergoing. Insurance doesn’t cover the costs of the alternative treatments, which cost $2,800 a month, Graham said.

“It is so very important that he doesn’t miss any dosages so we have to make sure we always have the money on hand to order what we need when we need it,” wrote Graham on the Dylan Jones Cancer Support Group Facebook page. “He is also on a very strict diet so we can only feed him organic fruits and vegetables.”

The biggest fundraiser thus far has been Dollars for Dylan, which is set up at the Wepco Federal Credit Union in Oakland. GiveForward, another fundraiser, has raised $2,915.

On the GiveForward blog, Graham said she is not giving up and asks people to do the same.

“Even though our hearts are crushed we are not giving up,” wrote Graham. “The pain I’m feeling right now as my heart aches for my son is unbearable but I’m determined not to lose hope. I don’t know what God’s plan is here but I sure hope it’s to prove he can make miracles happen.”

Jones and the news of his fight against brain cancer has gone viral on social media, so much so that #DylanJonesFight started trending on Twitter, according to Graham. Celebrities like country music singer Wynonna Judd and Duck Dynasty have retweeted #DylanJonesFight and country music artist Colt Ford has stated on Twitter that he is praying for Jones.

Other fundraisers include Thirty One, Pampered Chef, hoagie, T-shirt and window sticker sales, as well as cash bash and band benefits. A campaign on Booster.com that is selling T-shirts has garnered $490.

Basketball players from Union, Keyser and Frankfort high schools recently wore gray, which is the color for brain cancer awareness, during their respective games in support of Jones.

The Kenny Jones Band of Keyser played at Schmitt’s Saloon in Morgantown earlier this month and raised $247 for Jones, according to their Facebook page. The band has been holding various fundraisers for Jones throughout the year.

Upcoming fundraisers include a bake sale at 7-Eleven in Oakland Saturday starting at 8 a.m. and band benefit on Feb. 8 at the Black Bear Tavern and Restaurant in McHenry from 7 p.m. until closing. The Dylan Jones Cancer Fund Facebook page, which has 3,260 members thus far, has updates on additional upcoming fundraisers.

Jones is a 2011 graduate of Union High School and following graduation he worked on his grandfather, Roy Jones’ farm in Elk Garden, according to Graham.

Jones is the son of Craig Jones of Mount Storm, the stepson of Jeremy Graham of Oakland, the brother of Brianna and Wesley Jones both of Mount Storm, the great grandson of floyd “Buck” Jones of Elk Garden, the grandson of Roy and Priscilla Jones of Elk Garden and Ramona and James Hanlin of Mount Storm.

Anyone wishing to send cards or donate may send them to the The Dylan Jones Cancer Fund, 3976 Mayhew Inn Road, Oakland MD, 21550. Donations can also be made on the GiveForward website at https://www.giveforward.com/fundraiser/4yk3/dylan-jones-cancer-fund  

Source: http://www.times-news.com/local/x1724065386/Outpouring-of-support-for-young-Oakland-man-battling-brain-cancer

A Former Teacher with Brain Cancer Talks Priorities

After A Cancer Diagnosis, Lessons In Priorities

Teaching high school English came naturally to David Menasche but a terminal brain cancer diagnosis forced him to leave the classroom. So he visited some of his former students to see what impact he’s had on them. He writes about the experience in his forthcoming book, The Priority List

TRANSCRIPT

CELESTE HEADLEE, HOST:

This is TELL ME MORE from NPR News. I’m Celeste Headlee. Michel Martin is away. Christmas is here and later in the program, we have a special gift for you. Some of our favorite conversations of the year from translating hip-hop lyrics into sign language, to a legendary musician turning personal grief into powerful song. First, though, a teacher who’s inspiring his students less with his lesson plans and more with his life.

David Menasche taught English in a Miami high school for years. But as he approached the final stages of terminal brain cancer, Menasche decided it was time to hit the road. He spent more than a hundred days traveling hundreds of miles by train and car visiting some of his former students. And he wrote about the journey in a upcoming book called, “The Priority List: A Teacher’s Final Quest to Discover Life’s Greatest Lessons.” And he joins me now. David, welcome to the program.

DAVID MENASCHE: Thank you, Celeste.

HEADLEE: It wasn’t after you got diagnosed that you decided to go on this trip. What’s shocked me a bit was that it was after you’d actually lost a large…

MENASCHE: Exactly.

HEADLEE: …Portion of your vision when it would be the hardest – the most difficult, it seems to be, to go traveling. Why then?

MENASCHE: Well, it wasn’t the diagnosis of brain cancer that got me motivated to go on the trip. It was actually this past July 10, 2012, I suffered a stroke that took away the left side of my body and half of my vision. And at that point, I realized I couldn’t teach anymore, as I couldn’t drive. I couldn’t even get to work, much less watch a over a class of 30 students. So bored, frustrated and feeling purposeless, I decided to take a trip to go visit my former students. So I put a post on Facebook, and within 48 hours, I had offers in 50 different cities, which led to a trip of over 8,000 miles, 75 different students and different couches, over 101 days, and as you said, a book.

HEADLEE: So did you basically decide to visit each student that invited you on Facebook? Or did you…

MENASCHE: Yes.

HEADLEE: …Pick and choose?

MENASCHE: No, my intention was to go see every single one of them, but unfortunately, because of circumstances – you know, kids get sick, people get pulled out of town, things like that happen – I didn’t get to see every single one of the students that I had got an offer from. But I did get the lion’s share of it. Making it all the way to the Pacific Ocean for the first time for me.

HEADLEE: So the question you were asking these students was what kind of impact did I have on your life, right?

MENASCHE: I wanted to know if I made a difference.

HEADLEE: Do you think you were able to get an honest answer from them? I mean, I would imagine that with you sitting right in front of them…

MENASCHE: Absolutely. I had quite a few students tell me, oh, I hated your class. You put me on the spot all of the time. I never felt prepared. But, you know, at the same time, I would ask them, did that in any way help you? And very frequently the answer would be yes.

You know, that being forced to think on their feet, being forced to answer questions ultimately was a benefit. But no, not all of them were, you know, just fawning over me, which was good because that’s what I wanted was an honest answer. But for the most part, I got a range within each one of them where they would say, this part of the class was amazing. This other part of the class, I could’ve done without.

Read more: http://www.npr.org/2013/12/25/256874611/sorting-priorities-after-a-cancer-diagnosis

A Woman’s Final Months Told Through Twitter

The Incredible Story Of A Woman’s Final Months Fighting Brain Cancer As Told Through Her Tweets

Source: http://www.buzzfeed.com/ryanhatesthis/the-incredible-story-of-a-womans-final-months-fighting-brain

Ivy Foundation Awards $3 Million Grant

Ivy Foundation awards $3 million grant, supporting brain cancer research in Arizona

December 18th, 2013
Dec. 18, 2013—The Ben & Catherine Ivy Foundation today announced a $3 million grant to the Translational Genomics Research Institute (TGen), Nemucore Medical Innovations Inc., and Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center to help fund significant brain tumor research in Arizona. The collaboration of TGen, Nemucore and Barrow will pursue ways to optimize targeted therapies delivered by nanotechnology systems to treat glioblastoma, the most common and most aggressive form of malignant brain tumors.

This project is a primary example of translational research, moving laboratory findings as soon as practicable to patient care. Laboratory success should result in eventual follow-on efforts in the biomanufacturing of personalized medicine and implementation of new therapies in clinical trials.

“We are excited about this innovative approach to research, especially the collaboration between two major Arizona institutions: TGen and Barrow,” said Catherine Ivy, Founder and President of the Ivy Foundation. “Knowing there is a tangible way to develop therapies specific to the needs of patients will enhance the care and treatment of every brain tumor patient—and that is priceless.”

One of the goals of this Ivy Foundation grant is to enable TGen, Nemucore and Barrow to collaboratively align their findings toward the goal of creating new medications that can bridge the body’s blood-brain barrier, which in the past has hampered the successful implementation of intravenous brain-cancer drugs.

Each of the collaborators is a leader in their respective fields:

  • TGen’s genomic sequencing—in which all 3 billion base-pair letters of human DNA are spelled out, in order—can be used to create molecular profiles of patients and match specific therapies to diseases, providing the promise of better clinical results while minimizing side effects.
  • Nemucore specializes in the development of life-saving cancer nanomedicines, in which drugs are packaged in ways that evade cancer defenses, delivering medications that can knockout tumors.
  • Barrow, which is internationally known for its treatment of neurological disorders and treats one of the highest volumes of brain tumors in the United States, will conduct preclinical work to design nanomedicines for better access to the tumor, and will also provide the setting for clinical trials, in which patients are the first to benefit from new therapies.

“Working with the research team from the outset of the study will be helpful. We can advise them on methods or components as they develop novel formulations suitable for crossing the blood-brain barrier,” said Dr. Tim Coleman, CEO of Nemucore. “Without this type of integrated approach it would take much longer to translate these individualized investigational therapies to the clinic.”

Based on the research findings, the team would work with a strategic manufacturing partner, Blue Ocean Biomanufacturing, to develop methods to manufacture personalized medicine for the treatment of glioblastoma.

Coleman also is CEO of Blue Ocean, which is developing a cutting edge, fully flexible manufacturing facility in Peoria, Arizona. With a focus on small-batch pharmaceuticals and personalized medicine, Blue Ocean will advance breakthrough technologies for producing biopharmaceuticals with reasonable economics. This revolutionary technology will make it possible to use the genetics of a single patient’s tumor to customize and produce the medicine specific to them.

“Barrow’s collaboration with TGen and Nemucore is unique in that we will develop novel drug delivery technology that fully spans basic academic science through bench top translation and manufacturing,” says Dr. Rachael Sirianni, assistant professor at the Barrow Brain Tumor Research Center. “Our first and foremost goal is to improve the prospects for patients diagnosed with glioblastoma, and to translate our academic science into safe and effective therapies. This innovative partnership between our respective institutions and the funding provided by the Ivy Foundation will make it possible to bring forward academic research to benefit patients at Barrow and elsewhere.”

“This grant is a tremendous step in changing the way medicine is developed in Arizona,” said Dr. Michael Berens, TGen Deputy Director for Research Resources and Director of TGen’s Cancer and Cell Biology Division. “This project should enable us to develop treatments that will bridge the blood-brain barrier. I wholeheartedly thank the Ivy Foundation for their continuing support of the work we are doing to find new and effective treatments for the patients afflicted with this most aggressive form of cancer.”

Provided by The Translational Genomics Research Institute