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Experimental treatment for brain tumors tested in Valhalla


Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)



Website: http://www.thejournalnews.com/apps/pbcs.dll/article?AID=/20060123/NEWS02/601230305/1027/NEWS11

Posted on: 01/23/2006

Experimental treatment for brain tumors tested in Valhalla

By THE JOURNAL NEWS
THE JOURNAL NEWS
(Original publication: January 23, 2006)

VALHALLA

After surgeons drilled two tiny holes in Janet Saitta's skull and threaded catheters through them directly into her brain tumor, Dr. Deborah Benzil delivered some good news.

"Supper's on the way," she said to Saitta, a 48-year-old mother of three from Yorktown, who had not eaten all day.

Saitta, who was awake but lightly sedated, laughed.

A few minutes later, after Benzil finished wrapping Saitta's head in gauze, Saitta smiled at the surgeon.

"I think you did a good job," she said. "Thank you."

About 45 minutes later in the neurosurgery intensive care unit at Westchester Medical Center, a pump began pushing an experimental medication made with diphtheria toxin through the catheters. A nurse ordered Saitta a turkey sandwich.

For the next four days, Saitta received the medicine that could be her best hope for beating a kind of brain tumor called a glioblastoma (pronounced glee-o-blah-STOW-mah). These tumors are so difficult to treat that the average survival for patients has improved by a mere two months over the past 25 years.

"We've tried a lot of things," said Benzil, a neurosurgeon at the medical center. "Surgery's gotten better and we deliver the radiation in a more sophisticated way. We've gotten better at handling the side effects of chemotherapy, and still the impact on the disease has been relatively small."

Saitta, a nurse herself, knew the odds when her condition was diagnosed in February as a tumor. She had been suffering an unrelenting headache for several days.

"Honestly, my first thought was, it's not the tumor I would have picked," Saitta said. "I know it's an aggressive, fast-growing one. That's OK. I was determined to fight it anyway."

Brain or spinal-cord tumors were diagnosed in an estimated 19,000 people in 2005, according to figures from the American Cancer Society. The average survival time for those found with a glioblastoma is 18 months, Benzil said.

"It's really hard to see these other cancers, the treatments progressing and succeeding, and not to see that happening as broadly — maybe — for brain tumors," said Harriet Patterson, program director for the National Brain Tumor Foundation, a San Francisco-based group that funds research and educates patients.

The organization gets about 1,000 calls a month, many from patients who have scoured the Internet for treatment information and want details on particular clinical trials.

"I definitely feel that now, more than, say, five years ago, there's a much better feeling that there is promise in some of the research that's coming out and that there may be some movement around the corner in terms of better treatments," Patterson said.

Saitta's treatment choice was obvious after the tumor was revealed by a CT scan taken at Hudson Valley Hospital Center in Cortlandt, where Saitta was a nursing supervisor and emergency-department nurse. The tumor was in a place where it could be removed, and Benzil operated to take it out. The surgery was followed with a combination of chemotherapy and radiation.

One reason brain tumors are so difficult to fight is that chemotherapy won't readily penetrate the so-called blood-brain barrier, which is designed to keep out infections, Benzil said.

"It won't ever get into the brain in concentrations suitable to kill the tumor cells," she said.

Saitta was feeling good after her treatments, but began to have some headaches. Benzil operated again in September and found that the tumor had returned. Now, Saitta was moving into the realm of experimental treatments.

Saitta and her husband, Rick, researched clinical trials all over the country. There are some 100 taking place now for brain tumors, including one using a medication made with a synthetic form of scorpion venom and another that has already been successful in treating colon cancer. If Saitta joined one trial at a major cancer center, she would not know until she was in the operating room whether she was chosen to receive the actual treatment or the treatment used for comparison.

"I was horrified at that idea," Rick Saitta said.

Early on in Saitta's illness, Benzil had mentioned a clinical trial with a new medication called TransMID. It was time to consider it.

Benzil said the treatment was unique in two ways. First, the medicine would be delivered directly into the tumor, eliminating the problem of it having to cross the blood-brain barrier. Second, it contained an iron-related compound that latched onto receptors on the outside of the tumor cells. Then, an altered form of the diphtheria toxin entered the cells to destroy them.

"The toxin gets activated or turned on, then it basically kills the cell," Benzil said.

The basic science for this type of treatment was started about two decades ago at the National Institutes of Health, Benzil said. It has finally resulted in a medicine that is being tested in the last phase, or Phase 3, of clinical trials before its manufacturer can seek government approval to sell the drug, she said.

The Saittas liked the approach. They also liked that the treatment could be delivered close to home.

"This is the only one that made sense to me," Rick Saitta said.

Saitta first had to meet the criteria for the trial and hoped she would be picked, or randomized, to get TransMID. In this trial, which is taking place at about two dozen centers across the country and others internationally, two patients are picked to receive TransMID for every one who is chosen to get standard treatment such as chemotherapy.

The drug company makes the selection by computer. Right after Thanksgiving, Saitta learned she would get the TransMID.

Saitta's treatments were set up to avoid interfering with Christmas. She had the first one in late November and returned to Westchester Medical Center on Jan. 9 for the second and last treatment.

Pinpointing the tumor's location and positioning the catheters accurately were paramount to the treatment's success.

To get the right measurements, Benzil and a neurosurgery resident, Dr. Avinash Mohan, screwed a metal frame onto Saitta's head. She was then taken for a CT scan.

Benzil looked at the image and said the catheters needed to be about a half-inch apart and about a half-inch from certain structures in the brain. She pointed to the motor strip, which controls movement, at the edge of the brain.

"We can't pass the catheter down this track because we would go right through her motor strip and give her weakness on the other side of her body," she said.

A computer assigned coordinates for the tumor. In the operating room, a second metal frame was put on top of the first, creating a box around Saitta's head. The surgical team was then able to map out the coordinates and place the drill and instruments in the right spot.

Although the actual procedure took about an hour, Saitta had to wait more than three hours for it to begin — through lunchtime — because of some computer glitches.

"I'm here," she said, when she was wheeled into the operating room about 3:15 p.m.

Although the drill was mechanical and quiet, Saitta said later that she could hear it. But she did not feel anything, she said.

The TransMID was to be dripped into her head at a rate of about a teaspoon a day. That rate would not overwhelm her brain with fluid and cause swelling.

Benzil said it was too soon to tell if the treatments had shrunk the tumor.

In earlier clinical trials of TransMID, 35 percent of the patients had their tumors reduced by more than 50 percent and experienced an increase in life expectancy, said the drug's manufacturer, the Xenova Group. The current trial, in which more than 100 patients have been enrolled, is expected to continue for at least another year.

"Even if this trial isn't successful, we will have learned a tremendous amount about how to place these catheters, how to deliver agents," Benzil said. "So if this trial doesn't work, we should still be one step closer to something that will."

On Jan. 13, the last full day of treatment, Saitta said she felt fine. She said it would have been nice to hear there had been progress.

"I would love to hear somebody say goodbye, go home, never come back," she said. "But I did know at this point, I wouldn't know anything yet. I'm just hoping that down the road, weeks or months, whenever the next MRI is ... I will indeed see improvement."

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