A costly experimental treatment for terminally ill kidney cancer patients is being offered at reduced rates by Hoag Memorial Hospital Presbyterian as part of a national clinical trial of 120 patients, the Newport Beach hospital announced Tuesday.
Pacific Coast Biotherapeutics, the medical laboratory that will conduct the trial with Hoag, said it will pay the $19,400 cost of special immunotherapy for patients who qualify for the study. The other costs, largely hospital and clinical charges estimated at $25,000 each, must still be borne by patients and their insurance companies, Hoag officials said.
Pacific Coast received approval from the Federal Drug Administration in May to begin using the experimental treatment, called "LAK-cell therapy," on patients with melanoma, a severe form of skin cancer, and on renal cell carcinoma patients, those whose cancer has spread beyond the kidney. Both are considered fatal and virtually untreatable by conventional means.
LAK-cell therapy, which in other trials has shown a higher success rate than conventional treatments, stimulates the body's own cancer-fighting defenses and artificially intensifies them, according to Dr. Neil Barth, medical director of Hoag's oncology program and of Pacific Coast Biotherapeutics.
So far, two kidney cancer patients at Hoag have undergone the therapy for a separate study, patient coordinator Joyce Roberts said. One of the patients has gone into complete remission. The other has been "stabilized," she added.
Dr. Steven Armentrout, chief oncologist at UC Irvine's medical school, said cancer specialists believe LAK-cell therapy is a "legitimate treatment" that has proved effective in certain cases of renal cell carcinoma.
Armentrout cautioned, however, that the treatment will still need years of perfecting. Side effects have included death, mental confusion, comas, respiratory distress, severe fluid retention, low blood pressure and other problems, he said.
"In renal cell carcinoma, it is . . . the best therapy that is available," he said, but he added that there is as yet "no clear evidence (that the treatment) increases survival."
Treatment involves injecting patients with an artificially produced form of interleukin-2, a natural substance in many mammals' immune systems. In response, the body sends its natural "killer cells" into the bloodstream.
The cells are then filtered from a patient's blood stream, cultured and "activated," Barth said, meaning they are the so-called Lymphokine-Activated Killer-Cells, or LAK cells. They are injected back into the patient along with more interleukin-2.
Barth said studies have shown the therapy to have a "30% to 50% response rate," which includes tumors that have gone into complete or partial remission.
As part of the new trial, about 30 patients would be treated at Hoag. The remaining 90 would be treated at the Scripps Clinic and Research Foundation in La Jolla, and at two medical centers in Tennessee.