Fox Chase Cancer Center Offers a "Personalized Vaccine" for Patients with Advanced Kidney Cancer as Part of a Clinical Trial
PHILADELPHIA (March 19, 2002) - Surgeons and medical oncologists at Fox Chase Cancer Center in Philadelphia have embarked on a unique, multi-center clinical trial for patients with advanced renal cell carcinoma or kidney cancer offering them a "personalized vaccine" to determine whether it will prevent cancer recurrence after surgery.
The vaccine, called "Oncophage�," is made by Antigenics, Inc. The US Food and Drug Administration has approved the use of the vaccine in clinical trials, and has recently granted "fast-track" status to the investigation of the vaccine as a treatment for patients with kidney cancer. Fox Chase Cancer Center is the only institution in the Delaware Valley participating in this national study, which is sponsored by Antigenics, Inc.
For kidney cancer patients with advanced disease, the standard of therapy is to surgically remove the tumor, or if the cancer is too extensive, remove the entire organ. Chemotherapy or radiation therapy is not generally recommended as a follow-up after surgery because additional or (adjuvant) therapy hasn't been proven effective for these patients.
"If the entire tumor is removed, we don't administer adjuvant therapy for these patients," says Naomi Haas, MD, principal investigator and medical oncologist at Fox Chase Cancer Center. "In this randomized clinical trial, we're trying to ascertain whether patients will possibly benefit from the personalized vaccine which should stimulate the patient's own immune system to fight against cancer recurrence."
"Patients who have positive lymph nodes or whose kidney tumor is excessively large are generally considered 'high-risk' for cancer recurrence," says Robert Uzzo, MD, co-investigator on the study and surgical oncologist at Fox Chase Cancer Center. "Preliminary results have shown that these personalized vaccines are promising, but we need to conduct further studies before making this the standard of care for patients with advanced kidney cancer," he added.
In the trial at Fox Chase Cancer Center, all of the patients undergo surgery to remove the cancerous tissue in the kidney. "The decision to remove the entire kidney or just the affected portion depends on tumor size and proximity to the main arteries that feed the kidney," says Uzzo. "We do everything possible to preserve the kidney so the patient can maintain function and avoid potential dialysis in the future," he says.
Surgeons remove the patient's cancerous tissue and send it to Antigenics, where the personalized vaccine is prepared by isolating heat shock proteins. Heat shock proteins are naturally-occurring proteins generated by cells especially when cells are stressed or shocked.
Since tumor cells have abnormal proteins, the heat shock proteins isolated from these cells have abnormalities as well. When these proteins are re-injected as a vaccine, the body can recognize them as abnormal and will create an immune response against the proteins, and the tumor cells that carry them. The vaccine should re-train the patient's immune system to identify and repress the cancer if it were to recur.
Approximately eight weeks after surgery, one group in the randomized clinical trial receives the personalized vaccine administered once a week for four weeks, then once every other week. The other group receives the standard therapy without vaccine and is closely monitored for tumor recurrence by expert medical oncologists. Patients in both groups are given regular CT scans so physicians can determine if the cancer reoccurs.
"If found effective, administering personalized vaccines after surgery for patients with advanced kidney cancer could potentially extend their lives and improve their quality of life," says Haas. "We're hoping that this therapy will prove to repress cancer recurrence in these patients."
Fox Chase Cancer Center, one of the nation's first comprehensive cancer centers designated by the National Cancer Institute in 1974, conducts basic and clinical research; programs of prevention, detection and treatment of cancer; and community outreach. For more information about Fox Chase activities, visit the Center's web site at www.fccc.edu or call 1-888-FOX CHASE.
Fox Chase Cancer Center, part of Temple University Health System, is one of the leading cancer research and treatment centers in the United States. Founded in 1904 in Philadelphia as one of the nation’s first cancer hospitals, Fox Chase also was among the first institutions to receive the National Cancer Institute’s prestigious comprehensive cancer center designation in 1974. Fox Chase researchers have won the highest awards in their fields, including two Nobel Prizes. Fox Chase physicians are routinely recognized in national rankings, and the Center’s nursing program has achieved Magnet status for excellence three consecutive times. Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research and oversees programs in cancer prevention, detection, survivorship, and community outreach. For more information, call 1-888-FOX-CHASE (1-888-369-2427).