According to results presented at the annual meeting of the American Association for Cancer Research, the cancer vaccine Oncophage® appears to produce significant immune responses in patients with metastatic melanoma. The Food and Drug Administration (FDA) recently granted fast track status to Oncophage® for the treatment of metastatic melanoma.

Melanoma is a cancer of the skin that usually begins in the form of a mole. The cancer can grow deep into the skin and spread to different parts of the body through blood or lymph vessels. It usually spreads first to lymph nodes that are near the site of cancer origin and when advanced, can spread to organs and other lymph nodes throughout the body. Treatment for advanced or metastatic melanoma may consist of surgery, radiation, chemotherapy and/or biologic therapy. However, the prognosis for patients diagnosed with this disease is poor, as melanoma typically does not respond well to standard therapies. Biologic therapy, or therapy used to stimulate the immune system to fight cancer, has demonstrated anti-cancer activity in the treatment of melanoma. Researchers are trying to expand the role of biologic therapy for melanoma, with many clinical trials underway evaluating this therapeutic approach.

Oncophage® (HSPPC-96) is a vaccine that is composed of components of the patient’s own cancer cells which stimulates the patient’s immune system to attack the cancer. Every cell in the body displays specific antigens (small carbohydrates and/or proteins) on their surface. The immune system relies on antigens to recognize “foreign” material, such as bacteria, viruses or cancer cells. Dendritic cells are specific immune cells that “present” foreign antigens to other cells in the immune system. The immune system then mounts an attack against foreign cells that display the antigen(s) that were presented by the dendritic cells.

Heat shock proteins (HSPs) are an important component of all cells and their many roles are becoming more apparent to researchers. One role of HSPs is to form a complex with antigens and “escort” the antigens to dendritic cells. HSPs of a cancer cell form a complex with antigens specific to the cancer cell. Clinical studies have revealed that when HSPs from a cancer cell loaded with antigens bind to a dendritic cell, the HSP/antigen complex is internalized and biochemical processes occur within the dendritic cell that further stimulate the immune system. First, this process allows the dendritic cell to “display” the antigens specific to the cancer cells to other immune cells to initiate an immune response against the cancer. In addition, this process has been shown to activate lymphocytes, which are very important cells of the immune system; induce dendritic cells to secrete cytokines, a substances released into the lymph that stimulates immune cells; and induce dendritic cell maturation.

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Oncophage® is prepared by isolating HSPs and antigens from a patient’s cancer cells. The HSP/antigen complexes are made into a vaccination which the patient receives once a week on an outpatient basis. The injected HSP/antigen complex stimulates the immune system to fight cancer cells elsewhere in the body. Results from one clinical trial evaluating Oncophage® involved 39 patients with metastatic melanoma who received Oncophage® after the surgical removal of their cancer. Eleven patients had no evidence of cancer following surgery and 28 patients had cancer that could not be completely surgically removed. Of the 11 patients with no evidence of cancer following surgery, three remained cancer-free for 231 to 621 plus days. Of the 28 patients with measurable cancer following surgery, 5 demonstrated an anti-cancer response to Oncophage®, with two entering complete remission (disappearance of cancer) for close to two years. The remaining three patients had their melanoma stabilized for 153 to 272 days. There were no significant side effects related to Oncophage®. Results recently presented at the American Association for Cancer Research meeting indicated that half of the patients evaluated developed an immune response against their cancer specifically related to Oncophage®.

These results indicate that Oncophage® may produce anti-cancer responses in some patients with metastatic melanoma. This is important as patients with stage of melanoma have very few treatment options and suboptimal long-term outcomes. Patients with metastatic melanoma may wish to speak with their physician about the risks and benefits of participating in a clinical trial evaluating Oncophage® or other promising therapies. Two sources of information regarding ongoing clinical trials include the National Cancer Institute (cancer.gov) and www.eCancerTrials.com eCancerTrials.com also provides personalized clinical trial searches on behalf of patients. (Antigenics. Antigenics' Personalized Cancer Product Yields Promising Immunological Results in Melanoma and Colorectal Cancer Trials. Available at: http://investors.antigenics.com/ireye/ir_site.zhtml?ticker=AGEN%26script=418%26layout=0%26item_id=276540. Accessed April 9, 2002)

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