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Streamlining the Clinical Trial Process

Innovation and an uncompromising approach to top-of-the-line care are at the heart of Fox Chase Cancer Center’s mission to prevail over cancer. With an ever-evolving need for personalized care, Fox Chase clinicians have now more than ever taken a closer look at how clinical trials can be improved to enhance their vital role in that care.

The pace of oncology discovery continues to move quickly, with new and exciting treatments constantly being introduced. However, these rapidly emerging therapies also require effective testing methods and greater access for patients. Successes in these areas have occurred in kidney, bladder, and prostate cancer, where over the past 15 years, new therapies have been brought to patients through clinical trials.

With this in mind, Fox Chase has taken a head-on approach to improving the ways in which its clinical trials are selected, launched, and run, as well as to how patients are cared for and data is collected. Through a recently created clinical trials council, Fox Chase has pioneered new approaches to the overall structure and infrastructure that supports clinical trials.

Through a new system called TRACSS (Trial Resource Allocation and System Support), nine teams of researchers focused on different cancer types are allocated a specific number of clinical trials. These are based on how many patients are typically seen at Fox Chase for a particular disease, as well as the number of previous clinical trials conducted for it. With this approach, Fox Chase has been able to increase enrollment while also narrowing the focus of clinical trials by helping the research teams determine which trials have the best chance of success.

Additionally, Fox Chase is working on improving the availability of information surrounding their clinical trials. These measures include tools like infographics that make clinical data both more digestible and transparent for patients and physicians.

Fox Chase is also in the process of developing new tools to ensure that physicians are better equipped to match the best candidates with the appropriate trials. Within the past year, these changes have not only helped to increase the number of accrued patients but have also led to trials opening more quickly.

Improved access to clinical trials and the development of streamlined processes for their progress are paramount to the investigation of potential life-saving therapies. With these new and improved tools, researchers at Fox Chase believe that more of their patients will be among the first to have access to life-changing therapies through clinical trials.

Helping Men Avoid Prostate Surgery

Fox Chase researchers are recruiting for a clinical trial called PRESERVE that will evaluate the safety and efficacy of the NanoKnife System to destroy prostate cancer cells. One of the measurements of treatment effectiveness is to assess the number of patients that were able to avoid surgery to completely remove the prostate.

NanoKnife is a focal therapy, a form of treatment that is typically considered less invasive and that can eliminate cancer cells through different forms of energy such as heat and cold, all while sparing normal cells.

“I think this technology is the future, and I’m hoping that in 10 to 15 years I’ll be doing surgery to remove the prostate in a very limited number of patients. Those types of procedures really affect a patient’s quality of life, and if we can avoid that it would be ideal,” said Andres Correa, MD, an Assistant Professor in the Department of Urology and one of the clinicians heading the trial.

“NanoKnife is a technology that uses electricity to create a very high voltage between two probes. The lesion that has been identified and biopsied beforehand is placed between these probes and the electricity disrupts the integrity of cells, what we call the cell membrane. That’s how the cancer is affected,” he said.

Now Offering Adaptive Radiation Therapy

Fox Chase has begun offering cone-beam computed tomography-based adaptive radiation therapy, a technique that allows a patient’s radiation treatment to be adjusted in real time to accommodate changes in the body such as tumor shrinkage and/or the position of the adjacent normal organs.

In addition, adaptive radiotherapy is designed to enable more precise tumor targeting and more accurately deliver the treatment as the physician intended. Fox Chase is the only hospital in the Philadelphia area to offer this type of therapy.

“Now, not only can we adjust the position of the patient, but we can adjust the radiation plan itself in real time on a daily basis to take into account what’s in front of us. We view this as an advanced way of safely giving a large dose of radiation to the cancer and protecting the normal healthy cells at the same time,” said Eric Horwitz, MD, FABS, FASTRO, Chair of the Department of Radiation Oncology at Fox Chase and the Lewis Katz School of Medicine at Temple University.

New Data on Potential Bladder-Sparing Treatment

Half of the experimental group of muscle-invasive bladder cancer patients successfully kept their bladders and reached the two-year endpoint of the RETAIN BLADDER phase 2 clinical trial without developing metastatic cancer, according to final results presented by Fox Chase researchers at the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium.

Although the researchers just missed meeting their overall benchmark for two-year metastasis-free survival in the entire group of patients, the results will inform the subsequent RETAIN BLADDER II and III trials, said Daniel M. Geynisman, MD, Associate Professor in the Department of Hematology/Oncology, who headed the study.

“Whether it’s in the next trial or the trial after that, we’re continuously trying to, in an iterative process, improve upon the way we’re treating patients, preserve quality of life, and provide some options for organ preservation,” said Geynisman.

Diversity in Early Development Clinical Trials

Researchers at Fox Chase Cancer Center were awarded a $550,000 grant from Stand Up To Cancer (SU2C) to fund a new project, “Accelerating and Diversifying Access to Clinical Trials.” Temple Health matched the grant, bringing the total to $1.1 million for this effort.

“All of the pieces have been in place, including an extensive clinical trials program at the historic Fox Chase Cancer Center in Northeast Philadelphia, community outreach in North Philadelphia, and a diverse population at Temple University Hospital,” said Martin Edelman, MD, Associate Director for Clinical Research Integration and Chair of the Department of Hematology/Oncology at Fox Chase and Chair of the Department of Medical Oncology at the Lewis Katz School of Medicine at Temple University. “What we’re doing now is bringing them together to better serve our patients who are seen by Fox Chase and Temple University Hospital.”

Part of this effort has been to extend the collection of biological specimens such as blood and tissue from cancer patients at Temple Health for cancer research. Extending this biobanking capability to the main Temple Health campus enhances the diversity of the populations to be evaluated and the generalizability of results.

Edelman will be working with Linda Fleisher, PhD, MPH, Research Professor in the Cancer Prevention and Control Research Program, on improving clinical trial access through funding from the SU2C Diversity in Early Development Clinical Trials Research Grants Program.

A Cancer Prevention Vaccine

A Fox Chase researcher is participating in a clinical trial for a vaccine designed to train the immune system to protect patients against cancer as soon as it shows signs of developing.

The vaccine is being studied to see if it can protect those with a specific genetic condition called Lynch syndrome, which puts individuals at risk for developing cancer at some point in their lifetime. The vaccine test is the first step to learn if it can prevent these people from developing colorectal cancer later in life.

“Lynch syndrome is one of the most common hereditary causes of colon cancer. It affects about one in 300 people, but frustratingly, it’s often only with a cancer diagnosis that people get tested, which misses the chance to prevent that cancer,” said Michael Hall, MD, Chair of the Department of Clinical Genetics and the leader of the Fox Chase trial.

“If you can, perhaps, identify patients with a genetic propensity for cancer, and vaccinate them early in life, even if that cuts down their chance of cancer by 50%, that’s a huge difference in their quality of life and in savings for society.”