PRNewswire-USNewswire/ --The Swedish Neuroscience Institute today announced that the Ivy Brain Tumor Center has launched two separate clinical trials for treating brain cancer. The first trial (IND No. 10206, Protocol No. 020221, Study Agent: DCVax Brain - Autologous Dendritic cells and GBM tumor lysate) sponsored by Northwest Biotherapeutics, Bothell, Wash., is a Phase II clinical trial to investigate a groundbreaking personalized vaccine that uses a patient's own master immune cells combined with biomarkers from that patient's tumor tissue, to activate the master immune cells so they can mobilize the full immune system to recognize and kill the tumor cells. This type of tumor vaccine is used to strengthen the patient's own immune system to fight off the recurrence of the disease.

The second trial (IND No. 111046, Serial No. 000, "Phase 1 Study of the Metabolism and Distribution of a Subpharmacologic Dose of Lightly-labeled 14C-Temozolomide in Newly Diagnosed Glioblastoma Patients") tests a new approach to measure the effectiveness of the drug, Temozolomide (TMZ), in its activity against a patient's tumor.

This study is being done in partnership with Accium BioSciences in Seattle. A goal for the trial is to identify patients who are poor responders to TMZ early in their treatments so that physicians can pinpoint and select more effective drug strategies for each patient. GBM is the most common primary malignant brain tumor and one of the most fatal known to humankind. The incidence of GBM affects 22,000 people nationwide, including about 600 people in Washington state.  A typical survival rate for the disease is about 16 months.

The Ivy Center is currently enrolling patients in both of these studies. The principal investigator for these studies is Greg Foltz, M.D., director of the Ivy Center at Swedish and a nationally recognized brain cancer physician and researcher.

Brain Tumor Vaccine Explored

The first trial will test the DCVax immunotherapy agent, and is being sponsored by Northwest Biotheraputics, based in Bothell, Wash. This national trial will study thesafety and potential efficacy of autologous tumor lysate antigen.

DCVax is Northwest Biotherapeutics' platform technology, and uses a patient's own dendritic cells, which have been called "the starter engine of the human immune system."

Tumor vaccines are used to strengthen a patient's own immune system to fight off the recurrence of the disease, as well as to decrease or stabilize existing tumors. In this new study, the patient's own immune cells are extracted and trained to target the tumor. They are then re-introduced into the patient, where they can contain the tumor's growth or reduce its metastasis.

"So far, research results from the DCVax clinical trial have been promising and have attracted significant national attention from clinical centers nationwide," said Dr. Foltz. "We want to find new treatment options as quickly as possible. These trials hold great promise for researchers working to develop new, improved treatments for brain cancer tumors."

DCVax is an experimental autologous cellular therapy designed to create a specific immune response against a patient's own cancer. DCVax is manufactured using a patient's dendritic cells, loaded with a tumor cell lysate prepared from surgically resected tumor tissue. The dendritic cells are generated from monocytes obtained through a single leukapheresis.

In prior clinical trials of DCVax immune therapy for brain cancer, the results were striking: patients who received DCVax showed a median survival of three years, compared with median survival of slightly longer than 14 months, for patients who received today's standard of care (surgery, radiation and chemotherapy).

In addition, patients treated with DCVax did not have recurrence of their tumor for approximately two years, on average, as compared with tumor recurrence in just seven months with standard of care today. Moreover, the patients treated with DCVax did not experience any toxic side effects, in contrast to chemotherapies.

At this time, DCVax is available at the Ivy Center to patients with newly-diagnosed GBM.

"The number one thing brain cancer patients want is to have more treatment options, and to know that they can fight this disease from every angle," said Dellann Elliott, president and CEO of the Chris Elliott Fund for Glioblastoma Research, who co-founded CEF 3 weeks before her husband, Chris, died of GBM in 2002. "I know firsthand the words, we're sorry, there's nothing more we can do. The new brain tumor clinical trial studies at the Ivy Center bring hope to patients, and bring us one step closer to a cure."

Second Trial Tests Temozolomide

The second clinical trial directly tests the amount and activity of a chemotherapy drug, Temozolomide (TMZ) as it interacts with the tumor in individual patients. TMZ, a drug which received FDA approval in 1999, is standard therapy for treatment of newly-diagnosed GBM and melanoma. TMZ is taken by mouth and interferes with cell growth via DNA methylation, which triggers cell death. When given to patients with brain cancer, clinical studies have found that TMZ has been shown to improve median survival from 12 to 15 months. Not all patients benefit equally from TMZ administration, however. Tumor cells in some patients are able to repair the DNA methylation caused by TMZ, diminishing its therapeutic efficacy.

The goal of this trial is to identify early on patients who are poor responders to TMZ treatment.  This early identification will facilitate future clinical trials designed to optimize a patient's treatment plan by using other treatment modalities. The trial is made possible by accelerator mass spectrometry (AMS), an ultra-sensitive technique that measures TMZ-induced changes in individual patient's tumors. Accium is leading the development of new AMS applications that cover a wide range of research, from in vitro cell culture studies to understanding tumor uptake of drugs in individual patients, a goal of the current study.

The study is designed to ensure that existing methods of drug delivery and AMS measurement are adequate to measure the activity of TMZ in an individual patient's tumor at the time of surgery. If successful, the results will be used to design an appropriately powered follow-up study to identify those biomarkers that predict TMZ response. The study will also test whether patients, who are classified as TMZ high-responders and low-responders, are distinguishable based upon one or more TMZ-derived biomarkers. All of these tests can help identify a biomarker that is predictive of clinical response to TMZ therapy for each patient.

"This research is promising and these trials hold great promise for identifying a biomarker that is a more accurate predictor of clinical response to TMZ therapy," Dr. Foltz said. "These trials should help us discover which GBM patients respond better to this treatment than others. In turn, this will allow the design of more effective clinical trials testing new treatment modalities in combination with TMZ in the low-responder patient population."