New cancer therapy in clinical trial at Nebraska Medical Center has … – Omaha World-Herald

Posted: August 1, 2017 at 9:48 am

By the time scans showed that his B-cell non-Hodgkin lymphoma was coming back last fall, James Olson had run through many of his treatment options.

In early January, his doctor recommended that the Kansas City, Missouri, man travel to the Nebraska Medical Center in Omaha to see whether he was a candidate for a new type of therapy still in clinical trials.

In May, Olson, 69, received an infusion of his own immune cells, which had been removed from his body and modified to recognize and attack the cancer. Known as CAR-T or chimeric antigen receptor T-cell therapy, it represents a new way of targeting some cancers beyond that of traditional treatments.

About 10 weeks later, his scans are good and hes got the stamina to mow his lawn and do some house painting. Hes enjoying the little pleasures of life, even seasonal chores like installing a window air conditioning unit at his home.

His doctors at the medical center, meanwhile, hope theyll soon be able to offer CAR-T to more patients.

The trial that Olson participated in still is underway, and the medical center continues to accept new patients. Another version of the treatment has shown so much promise that its been fast-tracked by the Food and Drug Administration and could receive conditional approval late this fall. The medical center is set to participate in an expanded trial for that treatment, possibly as soon as this month.

Recently, an expert panel unanimously endorsed a version of CAR-T for children and young adults with recurring acute lymphoblastic leukemia. If the FDA clears the drug, medical center doctors hope to offer the treatment to young adults up to age 25. Theyd also like to see new trials with that drug or others for older adults with recurring ALL, as the leukemia is known.

These people need something else, and this may be it, said Dr. Matthew Lunning, a hematologist and oncologist with Nebraska Medicine.

The federal panels endorsement came at a time when a number of companies are racing to develop therapies based on the approach, which scientists first began to explore decades ago. If approved by the FDA, the Novartis product endorsed by the panel would become the first gene therapy approved in the United States. In addition to targeting relapsed lymphoma and leukemia, researchers also are beginning to study the therapy for solid tumors, the kind that start in organs or tissue. Leukemia and lymphoma are considered blood cancers.

Dr. Julie Vose, chief of hematology and oncology at Nebraska Medicine, said the therapy offers many bright spots in oncology.

We just have to learn how to use it in each specific disease and in each specific patient, she said, noting that the therapy is not a one-size-fits-all treatment as existing methods have been. We have to personalize that treatment.

But even with FDA approval, she said, the treatments potential side effects, which include fever and flu-like symptoms ranging from mild to extremely severe, mean it can only be done at specialized centers like the medical center. Indeed, one earlier trial was closed because some patients suffered serious complications.

Vose said trials in non-Hodgkin lymphoma all have produced good results, including the trial currently underway at the medical center and eight other sites nationwide.

Nationally, patients involved in the trial have had a complete remission rate of 60 percent after 30 days and 40 percent after 60 days. Officially, the condition is known as refractory diffuse large B-cell non-Hodgkin lymphoma, an aggressive disease that is among about 80 subtypes of non-Hodgkin lymphoma.

These were patients who had failed every other possible treatment, Vose said. And more than half had good response to the treatment.

Treatment for newly diagnosed non-Hodgkin lymphoma and acute lymphoblastic leukemia usually begins with chemotherapy. About 30 percent of non-Hodgkin lymphoma patients and roughly 40 percent of acute lymphoblastic leukemia patients relapse after chemo. The majority of those go on to have a blood or bone marrow transplant, from which about half will relapse.

Patients who relapse after the transplant, or those who arent candidates for a transplant, could be potential candidates for CAR-T therapy.

Unlike traditional gene therapy, however, CAR-T doesnt involve replacing disease-causing genes with healthy ones. Instead, technology is used to reprogram T cells, immune cells that normally help the body fight infection and cancer. In lymphoma patients, however, Vose said, T cells go haywire and dont properly fight cancer.

During treatment, the patients T cells are collected during an outpatient procedure and sent to a lab in California for processing. The patient then receives several days of intense chemotherapy. The modified T cells are returned to Omaha and put back into the patient, who is monitored at the hospital for seven to 10 days. The entire process takes about three weeks.

Olson, who drove to Omaha last week for a checkup, said he didnt really have any side effects from the procedure. I wondered if theyd given me a placebo, said Olson, who spent his working life in real estate and was diagnosed in 2010. He was well aware of the possible risks after reading and signing a 33-page consent form.

The next question, for patients and researchers alike, is how long the treatment will hold.

We dont know how long because this is such a new treatment, Vose said, but many of the patients (who) have been treated over the past year are doing well.

That question, like many in cancer treatment, comes with its own risks and benefits to balance. If half of the lymphoma is gone and it lasts years, Lunning said, thats better than a remission that lasts a month.

This report includes material from the Washington Post and Associated Press.

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New cancer therapy in clinical trial at Nebraska Medical Center has ... - Omaha World-Herald

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