NorthWest Biotherapeutics Inc (NWBO)

[john1045]

Brain Cancer Vaccine Breaks Through: DCVax

***Notice Compassionate Use LI Tumor Center for Neurological Surgery only one in US when patient is disqualified***

http://nursing.advanceweb.com/Features/Articles/Brain-Cancer-Vaccine-Breakthrough.aspx

Vaccine uses a patient's immune system to pass through the blood-brain barrier and recognize and kill the most deadly cancer cells.


By Joan Fox Rose, MA, RN

Posted on: January 31, 2014


Glioblastoma Multiforme (GBM), the most aggressive and lethal form of brain cancer, generally occurs in people in their 50s.

A primary, non-metastatic tumor its onset is gradual and brain dysfunction isn't apparent until damage has occurred.

Without treatment patients diagnosed with GBM have a life span of about 12 months.

A new, individualized vaccine is giving these patients new hope of extending their potential life span. DC Vax-L specifically targets each patient's immune system and is designed to recognize GBM cells.

The vaccine consists of two components: a substance prepared from personalized tumor cells and each person's dendrite cells (tree like structures within white blood cells), according to Michelle Almaliah, ANP, BC, a nurse practitioner and sub-investigator for the ongoing DC Vax-L III Clinical Trial at the Long Island Tumor Center of Neurological Surgery PC.

Although the vaccine won't prevent the onseet of GBM, researchers say it will hopefully fight and kill cancer cells when combined with concurrent treatments of radiation and chemotherapy.

DC Vax-L has extended patients' lives up to 36 months, Almaliah explained.



Standard of Care

All patients receive six weeks of chemotherapy and radiation that's prescribed after brain surgery. The chemotherapy drug Temodar (Temozolomide) is then prescribed for the next six months (or six cycles). It's prescribed for the first five days of each month.

"After tumors were surgically removed GBM had been difficult to treat because cancer drugs couldn't get through the blood-brain barrier, so our only options were surgery and radiation," said Lee Eric Tessler, MD, Neurosurgeon, Executive Director and Co-Surgical Director at The Long Island Brain Tumor of Neurological Surgery PC, a researcher and study team member.

Temodar can pass through the blood-brain barrier, and although it's revolutionized treatment options patients' life expectancy was only increased by a few months.

In an effort to extend patients' lives further the Phase III Clinical Trial Team, composed of a neurosurgeon, two neuro-oncologists, a nurse practitioner, clinical research coordinator, two oncology certified RNs and administrative staff, collaborated with Northwest Biotherapeutics, a pharmaceutical company based in Bethesda, Md. and manufacturer of the DC Vax-L vaccine.

"DC Vax-L uses patients' own immune systems, which allows the vaccine to pass through the blood-brain barrier that normally protects the brain," Tessler said. "As the vaccine interacts with patients' immune systems it doesn't produce toxicity. DC Vax-L isn't chemotherapy or the use of a drug. It's a step ahead because patients immunized by the vaccine live for years instead of months."

Clinical Trial Participation

Only patients diagnosed with GMB are eligible to receive the DC Vax-L vaccine, according to Almaliah. A potential subject is identified after an MRI is reviewed and a radiologist makes an educated guess about whether or not a tumor resembles the imaging of GBM. Prior to surgery all patients sign a tissue collection informed consent. The study requires a fresh collection of tumor tissue during surgery.

After surgery a pathologist tests and examines tumor tissue to confirm a GBM diagnosis. Then a special process is used to break down tumor tissue into miniscule particles called Lysate. A minimum of five vaccines are made from the Lysate process.

"The more tumor we have, the more vaccine can be made, and as long there's enough vaccine patients can continue to get it," Almaliah said. Once GBM has been confirmed patients are eligible to participate in the study. Tumor material from Ineligible patients is destroyed. Ineligibility occurs when patients don't have a GBM diagnosis.

Leukophersis

Three weeks after surgery patients undergo a procedure called Leukophersis (a process like hemodialysis) that's done to collect dendrite cells found in WBCs.

During this two-hour process dendrite cells are separated from the blood and harvested before blood is returned to the patient.

"DC Vax-L is called a dendrite cell vaccine because it teaches the body how to use WBCs to illicit an immune response," Tessler explained. "Through a laboratory procedure WBCs are introduced to Lysate (tumor material particles).Through this process WBCs become a dead antigen that's injected back into patient's bodies to help their immune systems to recognize and kill cancer cells."

Tumor tissue particles (Lysate), WBCs and placebos (made with WBCs only) are included in the manufacture of DC Vax-L vaccine. Once the manufacturing process is completed the vaccine is returned to the study site where patients receive it via an intradermal injection into the upper arm (it's like getting a flu shot).

The Phase III clinical trial is a double-bind study designed to prevent bias in test results. Neither patients nor Almaliah, the research team's sub investigator, know who gets the vaccine or who gets the placebo. "The study is a vaccine-
placebo process," Tessler said. "For every two patients immunized one gets the vaccine while the other gets the placebo. Should GBM progress in patients on the placebo- they also get the vaccine."

Compassionate Use Study

The Compassionate Use Study allows patients disqualified from the initial study to get the vaccine.

"Perhaps they had a procedure that was done too early and that's why they were disqualified," Tessler said. "At that point they're not in the trial, but as the vaccine has been made for them already they can get it. We're the first in the country to use this ready-made vaccine."

"And, we're the only center that does the compassionate use study," Almaliah added.

Clinical Trials: A Quest for the Future

"Clinical trials are part of the future to figure out how to treat tumors," Tessler said

"As a team we find trials to see what's out there, and some of our ideas may produce better ideas so we conduct our own trials," Tessler continued.

"To generate ideas we look to universities and clinical trials and treatments being developed in the industry. At this point we have 10- clinical trials in progress," he said. "Should patients with GMB be ineligible for our study we put them in other trials. Patients and healthcare professionals must always be on the lookout for options."


"Treatment for GBM is overwhelming for both patients and their families and their lives are literally turned upside down," Almaliah said. "The DC Vax-L trial requires the vaccine to be given on a very strict schedule, and we have to plan patients' lives as the vaccines are primed and treatments are given.

"Treatments are considered palliative because there's no known cure for this disease. As nurses we're well-versed in this disease process, and on a daily basis we triage calls, review critical lab values, coordinate care and infuse chemotherapy: we provide care and emotional support for our patients," she said.

"Our entire team is there for our patients and by the care we provide we give them hope," Julia Trokanowski, RN, concluded.

Joan Fox Rose is a registered nurse and freelance writer.