Prostate Cancer Treatment: Cancer Therapy Using The Body's Own Cells - Provenge
A new therapy that recruits the body's own cells to destroy tumors could become a new way to treat men with advanced prostate cancer -- if federal health authorities--the FDA, eventually approves the highly individualized treatment.
The first step toward approval by the U.S. Food and Drug Administration (FDA)was a meeting in March 2007 when an advisory panel met to weigh the fate of what some experts are calling, in a way, the first vaccine for any form of cancer.
The drug's maker calls the treatment "an active cellular immunotherapy," which company officials say involves using a patient's immune system to control cancer that has migrated (or metastasized) to bone and other sites.
Called Provenge, the therapy was developed by Dendreon Corp., in Seattle. It could prove to be an important addition to the treatment of advanced prostate cancer, doctors say, because so few medications exist to control the disease once it spreads (or metastasized).
Dr. E. Roy Berger, a prostate cancer specialist at John T. Mather Memorial Hospital in Port Jefferson, New York said FDA advisory committee recommendations are not cast in stone, he says, but the agency rarely votes against its expert panelists. He is involved in the therapy's clinical research, having brought 25 Long Island, New York men into the study. Neither Berger nor his patients know who has received the genuine treatment and who got a placebo.
Berger thinks it is a break-through therapy, which is custom-made for each patient. Immune system cells are extracted from participants and sent to a laboratory in New Jersey, where they are loaded with a highly specific protein called prostatic acid phosphatase. The loaded cells are then re-infused into selected patients. While flowing through the bloodstream, these cells seek out the immune system components called T-cells and prompt them to become cancer killers.
The laboratory-manipulated cells turn on once they are in the patient. It's the T-cells that kill the cancer. T-cells are known as orchestrators of the body's immune response.
Provenge differs from other cancer vaccines that have been studied. It centers on the body's dendritic cells, which are the ones loaded with the activated protein in the laboratory. These cells are on a specific mission when they are returned to the body.
It's not a drug, it's a biologic agent. It has very limited toxicity. Half of patients get a chill and fever, a feeling as if they're about to get the flu which is the only major toxicity.
One of the patients in the study had advanced prostate cancer, which had spread to his pelvis. His father died of prostate cancer. He received the therapy, not the placebo. He had three infusions, which is the total treatment and his cancer has completely stabilized.
So now we must still wait for FDA approval of Provenge for advanced prostate cancer treatment and therapy, which could be a few months away.
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