(PHILADELPHIA) Physicians initially diagnosed Phil Marfuta, 28, with tension headaches, which seemed reasonable to him since he is a busy graduate student studying physics at Princeton University. However, as the days went on his headaches did not subside, and when a CT scan and an MRI revealed two tumors, Phil underwent emergency surgery at the Hospital of the University of Pennsylvania.
One of Phil's tumors was a grade IV glioblastoma multiforme (GBM), which is the most aggressive form of primary brain tumor. Typically once diagnosed, the median survival time for a patient with a GBM is 12 months.
"That kind of news is the kind you don't want to have to call your family and tell them about," says Phil.
Phil's tumors had stopped responding to traditional chemoradiation treatment and to a clinical trial that added an immune modulator to his therapy. That's when he learned of the Cotara® trial.
Cotara is a monoclonal antibody that targets the DNA of cancer cells and carries a radioactive isotope to them, literally destroying the cancer cells from the inside out. GBMs are complicated to treat because filaments of malignant cells spread out like fingers from the tumor and take root deep in the surrounding tissue, making it difficult to remove them without damaging healthy brain cells. This approach targets the cancer cells, while sparing healthy tissue in the brain.
In November, 2006, Phil was treated in this clinical trial of Cotara. "It involved just catheters, so compared to a craniotomy, that sounded quite nice," recalls Phil. To-date, Phil's GBM has been stabilized
HUP is one of four sites participating in the clinical trail of Cotara, a biological "guided missile" for the treatment of GBM, a deadly form of brain cancer that is newly diagnosed in more than 10,000 Americans each year.
Phil feels very strongly about the importance of participating in clinical trials and has even posted an account of his experience on the Young Adults Surviving Glioblastoma's Web site.
"I'm very passionate about science and I really enjoy finding things out and experimenting. By participating in this trial, somehow I feel like I've actually done something tangible to help other people who are basically going through the same thing that I am going through. That's a small thing, but to me, it's a very active step and it makes me feel good that there's a contribution that I've made," says Phil. "I sincerely wish that people would take that step and participate in these trials."
"Based on the scientific rationale for Cotara, coupled with some positive but preliminary indications from previous trials, we believe it is important to study this approach as a new option for this deadly disease," says Kevin D. Judy, MD, Associate Professor, Department of Neurosurgery at Penn.
"One challenge in treating brain tumors is the difficulty of delivering therapeutic agents to the brain through the blood-brain barrier (BBB) – the physical shield that serves to protect the brain and central nervous system from potentially dangerous or infectious agents," says Myrna R. Rosenfeld, MD, PhD, Chief of Penn's Division of Neuro-Oncology. Cotara is delivered through a method called convection enhanced delivery (CED), which uses a catheter to bypass the BBB and target the specific tumor site in the brain. "This method enables us to treat GBMs with local therapy that does not have side effects elsewhere in the body," says Robert Lustig, MD, Clinical Associate Professor of Radiation Oncology at Penn.
The Phase 2 clinical trial is designed to evaluate a single Cotara infusion in patients with a first or second recurrence of GBM. The primary endpoints of the trial are to confirm safety and determine median survival time and median time to progression in patients treated with Cotara. Cotara has been granted orphan drug status and fast track designation by the U.S. Food and Drug Administration for the treatment of GBM.
Peregrine Pharmaceuticals, Inc., developers of Cotara, is working with the New Approaches to Brain Tumor Therapy (NABTT) to conduct the trial at Penn, Wake Forest University, Emory University, and the University of Alabama at Birmingham.
Editor's Notes: Dr. Judy, Dr. Rosenfeld, and Dr. Lustig have no financial interest in Peregrine Pharmaceuticals, Inc.
For additional information about the trial at Penn, call (215) 615-4590.
For information regarding the other sites, call (800) 694-5334 or visit www.clinicaltrials.gov/ct/show/NCT00128635?order=1
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