Click here to listen to a clip from “Sunday Sunrise” featuring Catherine Ivy discussing her work in saving patients with brain cancer through funding research.
Arizona philanthropist Catherine (Bracken) Ivy keeps her focus on those diagnosed with brain cancer
One $five-million-project is titled “Outliers in Glioblastoma Outcome: Moving the curve forward.” This five-year investigation seeks to discover why approximately two percent of glioblastoma multiforme (GBM) patients — the outliers — live far beyond the average survival time of 18 months. GBM is the most common and aggressive form of malignant primary brain tumor; 98 percent of people diagnosed with GBM live less than 18 months.
“A major challenge with brain cancer is that people survive such a short time,” said Catherine (Bracken) Ivy, founder and president of The Ben & Catherine Ivy Foundation. “If this research enables patients to live longer, clinicians and researchers will gain a better understanding of how this disease works, which will bring us time to move closer to a cure.”
“The tireless and dedicated support of programs like the Ivy Foundation is helping transform ideas into medical reality,” said TGen President and Research Director Dr. Jeffrey Trent.
By precisely identifying the billions of molecular building blocks in each patient’s DNA through whole genome sequencing, TGen researchers hope to discover the genetic differences between those patients who survive only a few months, and those who survive longer because their brain cancer develops more slowly.
Using these genetic targets, TGen researchers will identify those patients most likely to benefit from the current standard of care, and those who might best benefit from alternative or new experimental treatments.
“If we can identify patients who will likely only survive a few months on current standard of care regimens we can then prioritize those patients for personalized clinical trials,” said Dr. David Craig, TGen’s deputy director of bioinformatics and one of the project’s principal investigators.
First-in-Patient Clinical Trial Studies
In the second $five 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.
This 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.
“We expect to identify genes that play a crucial role in this cancer’s survival and that may be crucial to the survival of other types of cancer as well,” said Dr. Michael Bittner, co-director of TGen’s Computational Biology Division.
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 intends to team 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 get new drugs to patients faster, deliver combinations of drugs that 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 projects should significantly expand Arizona’s network of brain cancer experts.
“It’s a tremendous opportunity to find more solutions for the patient diagnosed with brain cancer,” said Ivy, who also is working to establish additional clinical trials in the Phoenix area, giving local patients more treatment options. “The clinical trials are very exciting because they can impact the patient today.”
Ivy’s Commitment to Brain Cancer Research
Ivy has investigated research institutions nationally and internationally, learning everything she can about how to cure brain cancer. She is determined to help find better treatment options and improve the quality of life for patients with brain tumors.
Because brain cancer is rare compared to many other cancers, it does not receive as much media attention, government funding or pharmaceutical industry support. Standard treatment involves removal of the tumor, though surgery fails to get all of the cancer. Surgery is followed by radiation and chemotherapy using a drug with limited effect for most patients. There currently is little else that can be done to extend life expectancy.
The status quo is not acceptable to Ivy. More than anything, she said, the Ivy Foundation wants to instill hope and solutions for people diagnosed with brain cancer.
The Ivy Foundation’s overarching goal over the next seven years is to double the life expectancy of brain cancer patients from 18 to 36 months. And in working with TGen, Ivy said she has found three key values that align both organizations:
- Patient-focused research.
- Conducting the best research possible in a cost-effective manner.
- Making progress immediately.
“I hope that people with brain cancer and brain tumors know that there is a community of people working very hard to try and help them,” Ivy said. “We’re not saying we’re going to cure it tomorrow, but at least we’re moving the needle. We will never give up until we find a cure.’’
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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/115330378249248717618/posts
LinkedIn: Ivy Foundation http://linkedin.com/company/the-ben-and-catherine-ivy-foundation
YouTube: IvyFoundationGBM http://www.youtube.com/user/IvyFoundationGBM
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.
by Ken Alltucker – Jul. 10, 2012 06:22 PM
The Republic | azcentral.com
A local brain-cancer foundation’s $10 million in grants to TGen started with a question: Why do 2 percent of people with an aggressive type of brain cancer defy the odds and live much longer than others?
Researchers at Translational Genomics Research Institute, or TGen, will use funding from Scottsdale-based Ben & Catherine Ivy Foundation to complete a five-year study that aims to uncover genetic clues to glioblastoma multiforme. The aggressive brain cancer has a median survival rate of about 18 months, though about 2 percent of disease-sufferers live longer.
“Everyone asks how we can cure this disease by focusing on the 98 percent” of people who die within 18 months of diagnosis, said Catherine (Bracken) Ivy, founder and president of the Ivy Foundation. “Nobody has researched why the 2 percent live longer. Genomically, what is the difference?”
The Ivy Foundation will also underwrite a personalized medicine study by TGen that will match brain-cancer patients with drugs based on their genetic makeup.
A pilot study will start with 15 people diagnosed with brain cancer and use whole genome sequencing, which compares the genetic sequence of tumor cells with healthy cells to uncover genetic triggers for the disease. Based on that genetic information, people will likely receive investigational drugs in hopes of halting the disease.
After researchers gather information from the first 15 patients, they will conduct a feasibility study of 30 patients followed by a clinical trial with 70 patients, according to TGen. The study will involve a clinical-trials consortium of more than a half-dozen universities and groups funded by the Ivy Foundation.
Jeffrey Trent, TGen’s president and research director, said that a study with 100 or more people would make it one of the largest personalized-medicine trials.
Trent said that foundations focused on specific diseases will be an increasingly important source of funding for clinical trials that use personalized medicine. Research involving whole genome sequencing, in particular, can be painstaking and expensive, although technology has driven costs lower.
“Groups that fund research that augment (National Institutes of Health) are a huge part of the landscape,” Trent said.
The Ivy Foundation moved from the San Francisco Bay area to Scottsdale earlier this year and has funded more than $50 million in brain-cancer research in the U.S. and Canada. Its goal is to double life expectancy of glioblastoma patients from 18 to 36 months over the next seven years.
Ivy, a Phoenix native, launched the foundation in 2005 to honor her late husband, Ben Ivy, who died four months after being diagnosed with glioblastoma. She wants to expand access to clinical trails for Arizona residents with brain cancer.
“When you are sick, you want to be home,” Ivy said. “One of my primary objectives is to provide access to top clinical trials in Arizona.
“I want more available for the people of Arizona.”
New treatment approaches use the DCVax tumor vaccine and C-14 labeled Temozolomide to improve outcomes in brain cancer
SEATTLE, Wash. – September 21, 2011 – The Swedish Neuroscience Institute today announced that the Ivy Brain Tumor Center has launched two separate clinical trials for treating brain cancer.
The first trial (IND No. 10206, Protocol No. 020221, Study Agent: DCVax Brain – Autologous Dendritic cells and GBM tumor lysate) sponsored by Northwest Biotherapeutics, Bothell, Wash., is a Phase II clinical trial to investigate a groundbreaking personalized vaccine that uses a patient’s own master immune cells combined with biomarkers from that patient’s tumor tissue, to activate the master immune cells so they can mobilize the full immune system to recognize and kill the tumor cells. This type of tumor vaccine is used to strengthen the patient’s own immune system to fight off the recurrence of the disease.
The second trial (IND No. 111046, Serial No. 000, “Phase 1 Study of the Metabolism and Distribution of a Subpharmacologic Dose of Lightly-labeled 14C-Temozolomide in Newly Diagnosed Glioblastoma Patients”) tests a new approach to measure the effectiveness of the drug, Temozolomide (TMZ), in its activity against a patient’s tumor. This study is being done in partnership with Accium BioSciences in Seattle. A goal for the trial is to identify patients who are poor responders to TMZ early in their treatments so that physicians can pinpoint and select more effective drug strategies for each patient.
GBM is the most common primary malignant brain tumor and one of the most fatal known to humankind. The incidence of GBM affects 22,000 people nationwide, including about 600 people in Washington state. A typical survival rate for the disease is about 16 months.
The Ivy Center is currently enrolling patients in both of these studies. The principal investigator for these studies is Greg Foltz, M.D., director of the Ivy Center at Swedish and a nationally recognized brain cancer physician and researcher.
Brain Tumor Vaccine Explored
The first trial will test the DCVax immunotherapy agent, and is being sponsored by Northwest Biotheraputics, based in Bothell, Wash. This national trial will study the safety and potential efficacy of autologous tumor lysate antigen.
DCVax is Northwest Biotherapeutics’ platform technology, and uses a patient’s own dendritic cells, which have been called “the starter engine of the human immune system.”
Tumor vaccines are used to strengthen a patient’s own immune system to fight off the recurrence of the disease, as well as to decrease or stabilize existing tumors. In this new study, the patient’s own immune cells are extracted and trained to target the tumor. They are then re-introduced into the patient, where they can contain the tumor’s growth or reduce its metastasis.
“So far, research results from the DCVax clinical trial have been promising and have attracted significant national attention from clinical centers nationwide,” said Dr. Foltz. “We want to find new treatment options as quickly as possible. These trials hold great promise for researchers working to develop new, improved treatments for brain cancer tumors.”
DCVax is an experimental autologous cellular therapy designed to create a specific immune response against a patient’s own cancer. DCVax is manufactured using a patient’s dendritic cells, loaded with a tumor cell lysate prepared from surgically resected tumor tissue. The dendritic cells are generated from monocytes obtained through a single leukapheresis.
In prior clinical trials of DCVax immune therapy for brain cancer, the results were striking: patients who received DCVax showed a median survival of three years, compared with median survival of slightly longer than 14 months, for patients who received today’s standard of care (surgery, radiation and chemotherapy).
In addition, patients treated with DCVax did not have recurrence of their tumor for approximately two years, on average, as compared with tumor recurrence in just seven months with standard of care today. Moreover, the patients treated with DCVax did not experience any toxic side effects, in contrast to chemotherapies.
At this time, DCVax is available at the Ivy Center to patients with newly-diagnosed GBM.
“The number one thing brain cancer patients want is to have more treatment options, and to know that they can fight this disease from every angle,” said Dellann Elliott, president and CEO of the Chris Elliott Fund for Glioblastoma Research, who co-founded CEF 3 weeks before her husband, Chris, died of GBM in 2002. “I know firsthand the words, we’re sorry, there’s nothing more we can do. The new brain tumor clinical trial studies at the Ivy Center bring hope to patients, and bring us one step closer to a cure.”
Second Trial Tests Temozolomide
The second clinical trial directly tests the amount and activity of a chemotherapy drug, Temozolomide (TMZ) as it interacts with the tumor in individual patients. TMZ, a drug which received FDA approval in 1999, is standard therapy for treatment of newly-diagnosed GBM and melanoma. TMZ is taken by mouth and interferes with cell growth via DNA methylation, which triggers cell death. When given to patients with brain cancer, clinical studies have found that TMZ has been shown to improve median survival from 12 to 15 months. Not all patients benefit equally from TMZ administration, however. Tumor cells in some patients are able to repair the DNA methylation caused by TMZ, diminishing its therapeutic efficacy.
The goal of this trial is to identify early on patients who are poor responders to TMZ treatment. This early identification will facilitate future clinical trials designed to optimize a patient’s treatment plan by using other treatment modalities. The trial is made possible by accelerator mass spectrometry (AMS), an ultra-sensitive techniquethat measures TMZ-induced changes in individual patient’s tumors. Accium is leading the development of new AMS applications that cover a wide range of research, from in vitro cell culture studies to understanding tumor uptake of drugs in individual patients, a goal of the current study.
The study is designed to ensure that existing methods of drug delivery and AMS measurement are adequate to measure the activity of TMZ in an individual patient’s tumor at the time of surgery. If successful, the results will be used to design an appropriately powered follow-up study to identify those biomarkers that predict TMZ response. The study will also test whether patients, who are classified as TMZ high-responders and low-responders, are distinguishable based upon one or more TMZ-derived biomarkers. All of these tests can help identify a biomarker that is predictive of clinical response to TMZ therapy for each patient.
“This research is promising and these trials hold great promise for identifying a biomarker that is a more accurate predictor of clinical response to TMZ therapy,” Dr. Foltz said. “These trials should help us discover which GBM patients respond better to this treatment than others. In turn, this will allow the design of more effective clinical trials testing new treatment modalities in combination with TMZ in the low-responder patient population.
Funding provided by Seattle Brain Cancer Walk and the National Cancer Institute
Funding for the C-14-labeled Temozolomide trial has been provided partially by the National Cancer Institute and proceeds from the 2008 Brain Cancer Walk and 2009 Seattle Brain Cancer Walk as well as Accium BioSciences.
The 2011 Seattle Brain Cancer Walk is scheduled to occur this Saturday, September 24, 2011 at the Seattle Center. With less than a week to go, we are thrilled to announce an anonymous $500,000 Challenge Gift for this year’s walk. A current donor to the Ivy Center is making the anonymous gift to inspire additional gifts to the walk and to fund research like this. The donor will match all gifts made in support of the Seattle Brain Cancer Walk through December 31, 2011. (All donations made up to this point will count towards the Challenge Gift.) For more information about the walk, visit www.braincancerwalk.org orwww.Facebook.com/braincancer.
About the Ben and Catherine Ivy Brain Tumor Center
Opened in 2008, the Ivy Brain Tumor Center gives brain-tumor patients and their families access to a unique multidisciplinary team of skilled neurosurgeons, oncologists, radiologists and a specialized nursing staff to deliver coordinated care and innovative treatments for both benign and malignant brain tumors. The Ivy Center’s unique design places its world-class research facility directly adjacent to the out-patient clinic, providing patient instant access to promising new therapies discovered through gene-sequencing technologies. As part of the Swedish Neuroscience Institute located in Swedish Medical Center’s Cherry Hill Campus, the Ivy Center is the first brain tumor-specific community-based facility of its kind in the Pacific Northwest that enables scientists, researchers, doctors and patients to work collaboratively toward new treatment options for those diagnosed with all stages of brain tumors, including brain cancer.
About the Swedish Neuroscience Institute
In 2004, Swedish expanded its neuroscience services by establishing the Swedish Neuroscience Institute. The team of leading neurosurgeons and other specialists are building a world-class institute dedicated solely to the treatment and advancement of neurological disorders for patients in the Pacific Northwest and around the world. The Swedish/Cherry Hill Campus is the hub for the Institute and has been upgraded with four state-of-the-art operating rooms with intra-operative MRI and CT scanning, neuro-interventional radiology capabilities, a renovated neuro intensive-care unit, and a radiosurgery center with CyberKnife and Gamma Knife technologies for radiosurgical treatment of tumors throughout the body as well as other neurological diseases and disorders.
Swedish has grown over the last 100 years to become the largest, most comprehensive non-profit health provider in the Greater Seattle area with 8,500 employees, 3,000-physicians and 1,200-volunteers. It is comprised of four hospital campuses (First Hill, Cherry Hill, Ballard and Edmonds); emergency departments and ambulatory care centers in Issaquah, Redmond and Mill Creek; Swedish Visiting Nurse Services; and Swedish Medical Group – a network of more than 70 primary-care and specialty clinics located throughout the Greater Puget Sound area. Swedish recently opened a new emergency department and medical office building (MOB) on its Ballard campus and as well as its Issaquah campus. It will open a new hospital in the Issaquah Highlands in November. In addition to general medical and surgical care, Swedish is known as a regional referral center, providing specialized treatment in areas such as cardiovascular care, cancer care, neuroscience, orthopedics, high-risk obstetrics, pediatric specialties, organ transplantation and clinical research. For more information, visit Swedish online at www.swedish.org,www.swedishcares.org, www.facebook.com/swedishmedicalcenteror www.twitter.com/swedish.
In 2007, Swedish embarked upon an ambitious $100 million fundraising campaign. Campaign investments are used to support a wide-variety of initiatives throughout the health-care system, including cancer, heart and vascular, women and children, neurosciences, and orthopedics as well as programs to support underserved populations. To date, the campaign has secured gifts totaling more than $82 million. For more information or to support the campaign, visit www.campaignforswedish.org.