"Even after surgery, radiation and chemotherapy, this deadly brain cancer has a high likelihood of recurrence. This experimental vaccine is designed to harness the body's immune system to keep the cancer at bay," says Dr. Theodore Schwartz, site principal investigator and neurosurgeon at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, and associate professor of neurological surgery at Weill Cornell Medical College.
"Results from earlier trials are promising, and suggest that the vaccine may be able to improve both time to disease progression and length of survival," says Dr. Rose Lai, site principal investigator and neuro-oncologist at NewYork-Presbyterian Hospital/Columbia University Medical Center, and assistant professor of neurology in the Division of Neuro-Oncology at Columbia University College of Physicians and Surgeons.
Glioblastoma multiforme commonly causes memory, personality and neurological deficits, but may also produce seizures, nausea and vomiting, headache, and weakness on one side of the body (hemiparesis). The location of the tumor plays a role in what types of symptoms a patient may suffer. Until it is large enough, the tumor may not cause any symptoms. About 10,000 people are diagnosed with the disease each year.
An initial single-arm Phase II trial (ACT II) has reported promising preliminary data in 23 patients who received CDX-110. Median time to disease progression was 16.6 months and estimated median overall survival was 33.1 months. This compared favorably with data for a historical control group in which median time to progression was 6.4 months and median overall survival was 15.2 months.
The ACT III study will look at the effectiveness of the vaccine plus temozolomide in patients who are newly diagnosed with glioblastoma multiforme. Patients will receive injections into the skin every two weeks for three doses shortly after the completion of cranial radiation, followed by monthly injections for as long as the tumor has not returned. Temozolomide chemotherapy will be given one week after each monthly injection of the vaccine and continued for up to 12 cycles.
Qualifying patients must be 18 or older, have newly diagnosed and surgically resected glioblastoma multiforme. Interested patients should be screened for the study immediately following surgery. Qualifying patients must have cancer that expresses the protein epidermal growth factor receptor variant III (EGFRvIII). About 20 percent to 25 percent of patients with GBM express the EGFRvIII mutation. The vaccine is expected to work by activating the immune system against the EGFRvIII protein, shutting down the engine room of cancer growth in these patients. Patients must also have had a near total resection of their tumors and must be able to undergo combined radiation with temozolomide in order to qualify.
"If this approach is validated, vaccine therapy could be added on to the existing regimen of combined chemo-radiation," says Dr. Schwartz.
The study is sponsored by Celldex Therapeutics Inc. of Phillipsburg, NJ.
For more information about the study, patients may call (866) NYP-NEWS.
Cancer vaccines are intended either to treat existing cancers (therapeutic vaccines) or to prevent the development of cancer (prophylactic vaccines). Therapeutic vaccines, which are administered to cancer patients, are designed to treat cancer by stimulating the immune system to recognize and attack human cancer cells without harming normal cells. Prophylactic vaccines are given to healthy individuals to stimulate the immune system to attack cancer-causing viruses and prevent viral infection. Currently, two vaccines have been licensed by the U.S. Food and Drug Administration to prevent virus infections that can lead to cancer: the hepatitis B vaccine, which prevents infection with the hepatitis B virus, an infectious agent associated with liver cancer; and Gardasil®, which prevents infection with the two types of human papillomavirus that together cause 70 percent of cervical cancer cases worldwide.
For more information, visit www.nyp.org.
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