Neurosurgeons hope compound extends lives

Early-stage trials under way at Allegheny General approved by FDA

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John Rotella of Bridgeville began "losing names and what was going on."

Donald Marsh of Indiana, Pa. began having "dizzy spells and light-headedness."

Different symptoms but the same diagnosis: They each had a glioma, the most common form of a brain tumor. High-grade gliomas like theirs are rapidly progressive and often fatal.

The two also ended up having the same treatment at Allegheny General Hospital. There, with federal approval, neurosurgeons are studying a drug compound that makes it easier to cut out more of the tumor during open brain surgery, extending life expectancy.

Mr. Rotella and Mr. Marsh's surgeries were among the first 12 procedures done at Allegheny General since it got the OK from the Food and Drug Administration to do 50 of them.

The study is one of four early-stage trials around the nation to evaluate the safety and effectiveness of the compound 5-aminolevulinic acid, referred to as ALA.

Taken orally three hours before open brain surgery, ALA turns into a fluorescent substance when it enters cancerous tumor cells. When seen under a special blue light, the tumor then appears red amid the white color of the brain. That makes it easier for neurosurgeons to see -- and remove -- more of the tumor.

"Before we would have left more stuff behind," said Matthew Quigley, director of the division of neurosurgical oncology at Allegheny General, the primary investigator of the study and one of the neurosurgeons doing the procedures. The surgeons and the two patients spoke Thursday in a news conference on the study's progress.

"The tumor is notoriously difficult to remove," Dr. Quigley added. "Things that look normal are very infiltrated with malignant cells."

Those cancerous cells are invisible even with use of magnetic resonance imaging, or MRI.

"The advantage of ALA is it makes the landmark of the tumor much more [visible]," said Khaled Aziz, director of the hospital's Center for Complex Intracranial Surgery, who is also performing the surgery.

But the two surgeons emphasized that the ALA-aided neurosurgery is not a cure.

"We never use the word 'cure,' " Dr. Quigley said. "Surgery is a first step. We try to do our best first step and the better job we do, the better they do.

"It improves survival by about a third. That's what happens when you get the tumor out."

Dr. Aziz estimated they get at least 95 percent of the tumor using ALA but said subsequent steps for the study patients will be both radiation and chemotherapy, as is standard procedure for any glioma patient. Those two treatments are not part of the study.

When the study is over, Dr. Quigley said, he will ask the Federal Drug Administration for permission to do further study on another group of patients. And when that one is over, he'll look for another way to use the drug on the hospital's other glioma patients.

"I'm going to do everything in my power to make sure we don't lose it," he said.

During this trial, half the patients have had low-grade gliomas and half high-grades like those of Mr. Marsh and Mr. Rotella. The low-grade tumors are benign and more treatable but can become quickly cancerous.

So far, the surgeons said, the compound has failed to turn the benign tumors fluorescent. "The ALA does not appear to be effective for low-grade tumors," Dr. Quigley said.

Medical investigators in Germany noted the usefulness of the glowing effect of the compound in detecting the glioma cancer cells in a study published in the medical journal Lancet Oncology in 2006. The drug had previously been approved to treat a pre-cancerous skin condition.

The other medical centers involved in the studies are Advocate Lutheran General Hospital in Park Ridge, Ill.; Dartmouth-Hitchcock Medical Center in Lebanon, N.H.; and Case Comprehensive Cancer Center, Cleveland.

Mr. Rotella, 73, and Mr. Marsh, 72, meanwhile, feel like they are born anew.

"I'm here. I'm living. ... My life is a new life," said Mr. Rotella, who had his surgery Jan. 5 and was sent home two days later. Since then, many of the forgotten names he said he lost have returned, and the large scar on the left side of his head has healed and is barely visible.

Mr. Marsh underwent his procedure Monday. He was to be released from Allegheny General after the news conference.

How it works "is way over my head," he said. "But clearly it's working well for people."

Pohla Smith: or 412-263-1228.


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