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Return to Can a Vaccine Prevent Brain Cancer Recurrence? Overview

More on Can a Vaccine Prevent Brain Cancer Recurrence?

Can a Vaccine Prevent Brain Cancer Recurrence?

New York, NY (Sep 25, 2009)

Illustration of a human brain

Glioma, the most common and most deadly type of malignant brain tumor, is devastating for patients and their families. Patients usually live about a year or more with current standard therapy including surgery to reduce the tumor, radiotherapy, and temozolomide both during and six months post radiotherapy. Researchers at NewYork-Presbyterian Hospital and many other institutions are working toward more effective treatments for glioma, including those that harness the immune system.

Building on the promising results of earlier trials of a vaccine called CDX-110, Theodore Schwartz, MD, a neurosurgeon at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, and Rose Lai, MD, a neuro-oncologist at NewYork-Presbyterian Hospital/Columbia University Medical Center, are both enrolling patients in a Phase II multicenter trial (ACT III) of the vaccine. CDX-110 targets the growth factor receptor EGFRvIII, which is expressed on the tumor cells of about 25 percent of patients with glioma.

"In the earlier trials, a number of patients did very well for 1½ years to two years," said Dr. Lai. "The latest data from those trials show promising median survival, as well as overall survival. Median time to disease progression was 16.6 months and estimated median overall survival was 33.1 months. In the historical control group median time to progression was 6.3 months and median overall survival was 15 months. In these earlier phase II trials the survival benefit is considerable."

Drs. Theodore Schwartz and Rose Lai

The ACT III study will look at the effectiveness of CDX-110 plus temozolomide in patients newly diagnosed with glioma. "Patients will first have surgery to remove the tumor, and then they go into the standard of care therapy, six weeks of radiation and oral temozolomide," said Dr. Schwartz. "Two weeks after that is complete they get their first of three injections of the vaccine, each two weeks apart. Patients will continue to get one injection per month for the rest of their lives along with temozolomide once a month as maintenance therapy.

"Because there is evidence that the vaccine can potentiate the effect of the temozolomide, the monthly vaccine is scheduled for a week before the temozolomide," said Dr. Lai.

The study, initially designed as a randomized 2:1 trial of treatment or temozolomide, has been reconfigured so that all patients who enroll get the vaccine. Study subjects will be compared to historical controls.

Strict Criteria for Recruitment

Dr. Lai is aiming to recruit up to 20 patients in the trial, but added that the study has strict inclusion and exclusion criteria. "It is by no means a very easy trial to get into – we're very vigilant in our screening of patients," she said. Patients are ineligible if they have undergone chemo-radiation and still have a residual tumor of more than 1 cm square, or if they have more than one lesion. "Timing issues are also important for entering this trial," says Dr. Lai. "The patient would have to be screened probably before they start chemo-radiation or early during concomitant therapy to have a chance to get into the trial because the study starts two weeks after the completion of chemo-radiation."

The major criterion is that patients must be EGFRvIII positive. "We previously thought up to 40 percent of patients express EGFRvIII," Dr. Lai explained. "The current estimate of about 25 percent is certainly lower than previously reported, but that is our experience now, in this large clinical trial."

Patients in CDX-110 studies eventually had progressive disease. "When these patients underwent surgery their tumor tissue no longer showed the expression of EGFRvIII," said Dr. Lai. "The vaccine is actually effective in targeting the EGFRvIII population. While patients do recur somewhere down the road, it seems like the vaccine has been able to postpone the recurrence until much later."

"If this approach is validated, vaccine therapy could be added on to the existing regimen of combined chemo-radiation," says Dr. Schwartz. "The most important thing is that this trial really gives hope to a disease that doesn't have a lot of hope. We're working every day to try to improve the outcomes of patients with glioma, and this is just one of many avenues of investigation that we are pursuing at NewYork-Presbyterian Hospital."

Some patients who do recur after the CDX-110 trial may be eligible for another vaccine trial recently opened at NewYork-Presbyterian Hospital. Neurosurgeon Jeffrey Bruce, MD, at NewYork-Presbyterian/Columbia, has begun enrolling patients in a vaccine trial using a heat shock protein for patients with recurrent glioma.

The study is sponsored by Celldex Therapeutics Inc. of Phillipsburg, NJ.

Contributing faculty for this article:

Theodore H. Schwartz, MD is an Associate Attending Neurosurgeon at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, and an Associate Professor of Neurological Surgery, Surgical Director of the Comprehensive Epilepsy Center, and Co-Director of the Institute for Minimally Invasive Skull Base Surgery at Weill Cornell Medical College.

Rose Lai, MD is an Assistant Attending Neurologist at NewYork-Presbyterian Hospital/Columbia University Medical Center, and an Assistant Professor of Neurology in the Division of Neuro-Oncology at Columbia University College of Physicians and Surgeons.

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