A Patient-Focused Approach

Catherine (Bracken) Ivy, founder and president of The Ben & Catherine Ivy Foundation, has traveled the world learning all she can about brain cancer – specifically, how to cure it.

 

She is determined, through the efforts of her foundation, to find better treatment options and improve the quality of life for patients with brain tumors, especially those with glioblastoma multiforme (GBM), the most common and aggressive form of malignant primary brain tumor. Ninety-eight percent of people diagnosed with GBM live fewer than 18 months.

 

Because brain cancer is rare compared to many other cancers, research into the disease receives little federal funding, pharmaceutical industry support or media attention. Today, standard of care currently involves removal of the tumor (though surgery most often fails to remove all the cancer) followed by radiation treatments and chemotherapy involving a drug with limited effect for the majority of patients. Sadly, little else remains to extend life expectancy or remission.

 

This status quo is not acceptable to Ivy. More than anything, she wants the Ivy Foundation to provide solutions – and hope – for people diagnosed with brain cancer.

 

“I want people with brain cancer and brain tumors to know that there is a community of people working very hard to try and help them,” Ivy says. “We’re not saying we’re going to cure it tomorrow, but a least we’re moving the needle. Our immediate goal is to double life expectancy in the next seven years for people diagnosed with brain cancer. We will never give up until we find a cure.”

 

Leading the charge

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 says 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

 

“Those three things are not simple,” Ivy says.

 

But, she says, the innovative ideas of TGen President and Scientific Director Dr. Jeffrey Trent make her believe her efforts are worthwhile. The two first met at a brain cancer conference in Tucson, and at subsequent meetings Trent outlined research that would help the Ivy Foundation achieve its goal of advancing patient care.

 

As a result, the Ivy Foundation recently granted $10 million to TGen: $5 million each for two new groundbreaking brain cancer projects.

 

Discovering why some patients live longer

One $5-million project is titled “Outliers in Glioblastoma Outcome: Moving the curve forward.” This five-year investigation seeks to discover why approximately 2 percent of GBM patients – the outliers – live far beyond the average survival time of 18 months.

 

“A major challenge with brain cancer is that people survive such a short time,” Ivy says. “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 study the disease, providing the opportunity to move closer to a cure.”

 

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.

 

First-in-patient clinical trials studies

In the second $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.

 

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.

 

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 the University of California, San Francisco; the University of California, Los Angeles; the MD Anderson Cancer Center; the Memorial Sloan Kettering Cancer Center; the 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.

 

“It’s a tremendous opportunity to find more solutions for the patient diagnosed with brain cancer,” says 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.”

 

More information about TGen

 

More information about The Ben & Catherine Ivy Foundation

 

–       Text by Steve Yozwiak, TGen senior science writer

–       Photo courtesy TGen

 

At top: Catherine Ivy, founder and president of The Ben & Catherine Ivy Foundation, with TGen Deputy Directors Dr. David Craig (left) and Dr. John Carpten (right)

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