Advancing the standard of cancer care and offering patients access to new therapies

Our goal is to offer every patient the option of the latest treatment available. Norton Cancer Institute is participating in approximately 170 clinical trials at any time.

Our goal is to offer every patient the option of the latest treatment available for their cancer. To do that, Norton Cancer Institute is participating in approximately 170 clinical trials at any time.

These clinical trials involve nearly 500 patients either enrolled and receiving treatment, or in follow-up. For the participating patients, these studies offer hope. Many already have not responded to the front-line treatment or have exhausted standard treatment options entirely.

Our hemaologic malignancy program is the largest in our research portfolio, investigating treatments for myeloma, lymphoma, leukemia and others. We also participate in clinical trials for breast, central nervous system, head and neck, bladder, prostate, skin, lung, gastrointestinal, and gynecologic cancers.

Our providers are principal investigators on several potentially groundbreaking trials, including ones looking at chimeric antigen receptor T-cell therapy (CAR-T), natural killer T- cell (NKT), trispecific T-cell engagers (TriTE), and bispecific T-cell engagers (BiTE).

Trials can last anywhere from a few weeks to years, depending on the protocol design. Oncology treatment trials typically compare the investigational product to standard of care, since placebo-only trials are not ethical with cancer patients. Also, if a patient doesn’t respond well to the treatment on study, or if their disease progresses, the patient will come off the trial and receive a different treatment.

In addition to volunteering to participate in trials for potential new therapies, we have patients who help advance our understanding of cancer by consenting to donate specimens.

Norton Cancer Institute has played a role in dozens of therapies that have received Food and Drug Administration (FDA) approval and are now considered standard of care. One recent example: The FDA approved a new anti-PD-1/PD L-1 immunotherapy drug for metastatic bladder cancer following a phase 2 open-label trial in which we were a participant.

Norton Cancer Institute’s research program has an excellent reputation within the research industry and has long-standing relationships with several major pharmaceutical companies. We’re a preferred site with eight different companies, meaning we are often first to receive invitations to participate in trials with the latest investigational therapies. Because of this, we often open studies before other centers and often enroll the first participants in a particular trial. One example recently was that we had the first enrollment in the world on a Phase 1 study of an NKT treatment alone and in combination with approved checkpoint inhibitors in patients with solid tumors.

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Our research program also has become the 13th site in the nation invited to join the Early Phase Oncology Network as a preferred research site specifically for phase 1 trials.

Before we commit to opening a study, the research investigator and other members of the research team will review the protocol to make sure we have the correct potential patient population for the trial and have no competing studies for the disease condition. If we would like to proceed, we then conduct a feasibility assessment to assure that we have the right equipment, staff and facilities to support the trial.

If we are selected as a participating site, the study is submitted to the Norton Healthcare Research Office to complete startup activities with the legal, finance and regulatory teams, which takes on average three to five months. After that office approves the trial, the clinical team is able to initiate the trial and patients can begin enrolling.

We want to give our patients all opportunities for the best outcome, and we don’t assume that today’s standard of care is always the best option for each patient. It’s one way we do our part to help advance knowledge of cancer disease and improve treatment options for our patients.

Marti Gardner, MSN, R.N., CCRC, is system director, clinical research operations at Norton Healthcare.

Current Norton Cancer Institute clinical trials and studies

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