Brain Tumor Vaccine Seeks Candidates

Monica Robins Created: 2/12/2008 6:31:07 PM Updated:2/12/2008 7:28:05 PM

CLEVELAND -- University Hospitals Case Medical Center has opened a new brain tumor vaccine trial and candidates are needed.

Researchers in the Neurological Institute and Ireland Cancer Center at University Hospitals Case Medical Center are in late-stage trials for an experimental vaccine for the treatment of glioblastoma (GBM), the most aggressive form of brain cancer.

The new vaccine ? CDX-110 ? attempts to marshal the power of the patients? own immune system to fight against remnants of the tumor which typically remain in the brain following surgery and radiation treatment.

So far, the vaccine has been used to treat about 70 patients nationally with virtually no side-effects. Currently 14 patients have enrolled at UH, the only site in Ohio to have opened the study and one of 20 national sites.

At UH, the patients currently have had surgery and are now going through radiation treatment to shrink their tumors. They will then receive the vaccine to induce an immune response against the tumor.

According to UH neurosurgeon Andrew Sloan, M.D., early results, although not published, seem encouraging. Half of the patients receiving the vaccine have survived for more than 30 months after treatment.

?This is impressive considering that survival after standard treatment is less than a year. Even more impressive is the finding that 65 percent of patients treated with the vaccine were still alive after two years which is very rare for patients treated with conventional radiation and chemotherapy alone. In fact, several patients treated with the experimental vaccine have survived for more than three years,? said Dr. Sloan.

Normally, vaccines are used to prevent disease, but in this case, the vaccine is used to jump-start an immune response against an existing tumor.

The vaccine is designed to teach the body?s immune system to attack the tumor without attacking the normal brain cells. Another advantage of the vaccine compared to other experimental treatments is that there are few side-effects to vaccines.

Dr. Sloan, an Associate Professor of Neurosurgery at Case Western Reserve University with an NIH-funded grant to study the use of vaccines in brain tumors, said, ?This therapy has the potential to help not only patients suffering from this deadly disease, but if it lives up to its promise, it could potentially be used for other cancers as well.?

Glioblastoma is the most common form of adult brain cancer. It strikes more than 10,000 adults annually in the United States. It is highly malignant and the average survival is usually less than a year even after maximal surgical resection and radiation. Even the addition of a chemotherapy drug only adds an average of two months survival to patients? lives.

For more information or to enroll in the study call 216 844 6054.

Cross hairs on a cancer

An experimental brain tumor vaccine coaxes the immune system to attack diseased cells only. Trials on other cancers may follow.

By Bruce Goldman, Special to The Times
January 14, 2008

CANCER patients and physicians are always looking for therapies free of side effects. But the standard treatments available to them -- chemotherapy and radiation -- typically work via a shotgun approach, indiscriminately killing all rapidly dividing cells whether they're cancerous or not. A long-held notion that the immune response might, in some practical manner, be harnessed to target cancer cells while sparing the rest is now being put to the test.

An experimental vaccine is now in multi-center, late-stage trials for treatment of glioblastoma, the most common brain cancer in adults. If the therapy lives up to its promise, it could potentially be used for other cancers as well.

Glioblastoma, which strikes more than 10,000 adults per year in the United States, is a particularly aggressive form of brain cancer: Only one-half of patients survive for one year, even after radiation treatment and surgery to remove as much of the tumor as possible. The recent introduction of temozolomide, a chemotherapeutic drug, to the arsenal has added barely two months of survival to patients' lives.

Celldex Therapeutics Announces Orphan Drug Designation For CDX-110, A Novel EGFRvII Vaccine For Glioblastoma Multiforme

PR Newswire

December 7, 2007

PHILLIPSBURG, N.J. -- Celldex Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Celldex's CDX-110 for the treatment of EGFRvIII expressing Glioblastoma Multiforme (GBM). GBM is the most common and aggressive form of brain cancer. CDX-110 is an immunotherapy that targets the tumor-specific growth promoter EGFRvIII. Celldex Therapeutics announced a definitive merger agreement with AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) in October 2007.

In the ACTIVATE phase IIa study, CDX-110 treated GBM patients showed a median survival time of 30 months, more than a 100 percent increase in survival, versus the historical control's median of 14.5 months. The study has demonstrated a median time-to-progression of 13 months (p=0.0001) versus the historical control's median of 6.4 months. An extension study, ACT II, which combines CDX-110 with chemotherapy in a similar patient population, has not yet reached median time-to-progression or survival. However, preliminary progression free survival (PFS) and overall survival (OS) data in ACT II look very similar to the ACTIVATE experience, and the data suggest that chemotherapy and CDX-110 can be administered concurrently while still maintaining strong immune responses.

In September, Celldex randomized its first patient into ACT III, a definitive Phase II/III randomized study of CDX-110 with radiation and temozolomide in patients with newly-diagnosed GBM. The clinical trial is investigating the anticancer activity, impact on survival, and safety of the addition of CDX-110 vaccine to standard of care, versus standard of care alone. Celldex has currently enlisted 18 clinical centers throughout the United States, and also recently received approval from Health Canada to open enrollment in Canada. Furthermore, The National Cancer Institute (NCI) has agreed to collaborate with Celldex in expanded clinical development of CDX-110 under a Clinical Trials Agreement.

"Obtaining orphan designation for CDX-110 is an important milestone for Celldex," said Thomas Davis, M.D., Chief Medical Officer of Celldex Therapeutics. "Approval to expand clinical research into Canada and the scientific and clinical collaboration from the National Cancer Institute all promote our ability to fully explore the promise of CDX-110."