DHA, an Omega3 Oil - A possible synergist for tributyrin and DCA

Each day, Sam Hutchison swallows 44 pills, most of which weren't prescribed by his physician. They were chosen by Sam's father, who devised the treatment cocktail -- and tests many of the medicines on himself -- in a desperate effort to save his seven-year-old son.

Neil Hutchison, 45, isn't a doctor. A defense-contractor recruiter, he's part of a growing underground pushing the edge of medicine to find combinations of anticancer agents to save themselves or loved ones. Many of the medicines Sam takes haven't been tested in clinical trials for his disease. Some are meant for other illnesses; others are still in animal testing for safety and efficacy. But the fact is that Sam, who suffers a rare and often-deadly cancer of the nerves, is otherwise almost certain to die. Hence Mr. Hutchinson's decision, as he puts it, to play "lab rat" with his son.

"When your kids have run out of options, you have to think outside the box," Mr. Hutchison says. "It's terrifying, but it's our only hope."

Mr. Hutchison's methods are highly unorthodox. Doctors warn that untested combinations of drugs could cause terrible adverse reactions. Science takes time, and some doctors say that trying to shortcut the process is reckless.

But Mr. Hutchison is pursuing what many researchers believe is the most promising approach for curing or curbing cancer, which killed about 565,000 people in the U.S. last year. Because cancer seems to eventually overcome most individual therapies, researchers for a decade have advocated using combinations of new, targeted therapies on the theory that the best hope lies in cutting off all known avenues for the cancer to grow.

Trials of such methods have been slow to gain traction. "Everyone knows the future of cancer treatment lies in cancer cocktails," says David Kessler, dean of the school of medicine at the University of California, San Francisco. Dr. Kessler says the Food and Drug Administration needs to undertake an effort similar to one it did when he was commissioner in the 1990s, when it amended the drug-approval process to speed approval of AIDS-drug combinations. "What's missing today is leadership."

Richard Pazdur, director of the Office of Oncology Drug Products at the FDA, says he strongly believes in the cancer-cocktail approach, but says it's up to the "medical oncology field" to organize and implement such trials. He says drug companies struggle over how to collaborate on trials of therapies owned by several different firms. Others note the convention for testing drugs has been to prove efficacy individually in clinical trials -- and only later to evaluate combinations of drugs.

A growing number of people won't wait any longer. Thanks to the Internet, the sick and their families can read about scientific discoveries as they are published, track down scientists and doctors and share information and personal experiences. The handful of doctors and cancer survivors willing openly to advocate the do-it-yourself cocktail approach say they're now approached by a half-dozen to a dozen interested patients every week.

In charting their own course, patients and families often run afoul of their own doctors. Some physicians chafe at having patients grab control of treatment. Some worry that medicines not yet fully tested may harm patients and prompt malpractice lawsuits. "The patient could suffer terribly and die as a consequence. Who is ultimately responsible for that?," asks Marc Chamberlain, director of the neuro-oncology program at the Seattle Cancer Care Alliance, which includes the Fred Hutchinson Cancer Research Center.

The practice is particularly worrisome to those running clinical trials. While only a small minority of cancer patients are cobbling together their own cocktails, they're often the same people -- the desperate and the risk-takers -- who would otherwise volunteer for new drug trials. "The end result could be that we struggle to do clinical trials for new and improved therapies, and all of us would be alarmed by such an outcome," Dr. Chamberlain adds.

Nobody knows exactly what combination is most effective, how much of each drug to consume or how long the drugs should be taken. There are no statistics indicating how many patients have attempted to create their own cocktails or how successful their efforts have been.

Nick Pavlakis, a 40-year-old Australian oncologist who has helped patients put together combination therapies, says the cocktails don't work for everyone. Many patients give up because the side effects of the numerous drugs can be intolerable. For some, he says the cocktail seemed to hold the disease at bay only for a time.

But for some patients, the cancer cocktail appears to be the only medical explanation for remarkable recoveries.

The pioneer of self-directed cancer cocktails is Ben Williams, a behavioral psychology professor at the University of California, San Diego. In 1995, Mr. Williams was diagnosed with a glioblastoma, the most-deadly type of brain tumor, and was told he would likely die within 18 months.

As he received the standard radiation treatment, Mr. Williams combed scientific literature and became attracted to the idea of combining therapies. His neuro-oncologist, Dr. Chamberlain, then at the University of California, San Diego School of Medicine, initially refused to treat him with tamoxifen, a breast-cancer drug Mr. Williams had read could be helpful. But Mr. Williams eventually persuaded Dr. Chamberlain to add tamoxifen to a routinely prescribed chemotherapy drug.

Then, without telling Dr. Chamberlain, Mr. Williams added verapamil, a blood-pressure medicine that he had read made chemotherapy more effective, by asking another doctor to prescribe it. He bought Accutane, an acne treatment believed to kill cancer at high doses, in Mexico, where prescriptions weren't needed at the time.

Less than a year later, the tumor was gone. While he remains critical of the approach, Dr. Chamberlain says the treatment cocktail "probably contributed" to saving Mr. Williams's life.

Others followed Mr. Williams's route, with varying degrees of success. In 2002, a 55-year-old Australian real-estate developer named Donlevy Fitzpatrick was diagnosed with two brain tumors and given nine months to live. He and his wife learned of drug cocktails on the Internet, but couldn't persuade his neuro-oncologist to prescribe one. After Mr. Fitzpatrick lost his speech, his wife, Uschi, reached out in desperation to several experts including Mr. Williams, who helped her find an oncologist in Sydney -- Dr. Pavlakis -- willing to try the cocktail approach.

Treated with a cocktail including tamoxifen and Accutane, Mr. Fitzpatrick's tumor shrank until it was not detectable on brain scans. He regained his speech and his strength. "If Uschi had listened to what most oncologists recommend for brain tumors, Don would be dead," says Henry Friedman, a brain tumor specialist at Duke University Medical Center who also helped Mrs. Fitzpatrick.

At first, Neil and Margot Hutchison were content to follow the established medical regimen for their son. The couple, Sam and two younger boys share a 900-square-foot condominium in a beach community in San Diego. Mrs. Hutchison, easygoing and even-tempered, works as a literary agent. Her husband, a chemical-engineering major in college, is so intense he makes right turns at traffic lights -- even when his destination is straight ahead -- because he can't bear to stop moving.

In 2005, the red-headed, freckle-faced Sam took six rounds of high-dose chemotherapy, underwent surgery, a stem cell transplant and six months of treatment with Accutane. His immune system shot, his appetite gone -- along with his hair, eyebrows and hearing -- Sam spent 100 nights in the hospital that year.

The Hutchisons clung to hope: The cancers of about 80% of children go into remission. In August 2005, doctors declared Sam in remission.

But in July of 2006, a bone scan showed the cancer was back, in a small spot above his left knee. Neuro-oncologists delivered the grim prognosis: Children with recurrent neuroblastoma rarely live for long -- and there are virtually no survivors.

The Hutchisons were devastated. With nothing to lose, they signed up for a clinical trial of a drug called fenretinide, hoping to buy Sam some time. A little over a month later, a scan revealed two more cancerous lesions on Sam's right hip. Sam was dropped from the trial.

That night, Mr. Hutchison says he couldn't sleep. In the wee hours, he retreated to a storage loft that he had converted into a "war room" jammed with a desktop, three stacks of neuroblastoma books, boxes of vitamins and supplements and plastic tubs overflowing with printouts of his research.

Emptying the files on his desk, Mr. Hutchison began reading again. He found a paper another father had sent him. Physicians at Brown University had reported that a child with neuroblastoma who had contracted a tropical illness called Chagas disease went into remission after being treated with an antibiotic called nifurtimox. In a later lab test, nifurtimox appeared to kill neuroblastoma cells. Bayer AG, the German drug company, marketed the drug in other countries, but it wasn't licensed for sale in the U.S.

Mr. Hutchison phoned one of the paper's authors. The researcher, Giselle Sholler, had just begun experiments with mice and was several years away from human trials. But she agreed to treat Sam on compassionate use, a special provision for experimental treatments when all else has failed.

Back at Rady Children's Hospital in San Diego, the Hutchisons told Sam's oncologist Jennifer Willert of their plan. Although Dr. Sholler would be directing treatment from Vermont, the couple hoped the hospital would monitor Sam's progress. Initially they met with resistance. Dr. Willert says many of her colleagues strongly opposed treating Sam with the drug, arguing he should join another clinical trial instead.

But the Hutchisons were adamant. Dr. Willert agreed to supervise Sam's care, reasoning the antibiotic was unlikely to harm him.

In September 2006, Sam began nifurtimox in combination with two strong chemotherapy drugs, the same combination treatment the patient with Chagas disease had received when she went into remission at Brown.

By November, the cancerous spots on Sam's leg and hip were fainter. The Hutchisons posted Sam's progress online, and soon several other parents were clamoring to use the nifurtimox-chemotherapy combination. Dr. Sholler began a small clinical trial, with the support of a small foundation Mr. Hutchison helped start with another parent.

The Hutchisons were elated with Sam's progress, but feared the cancer could eventually overcome the nifurtimox. They wanted a backup.

Late one night in his war room, Mr. Hutchison stumbled upon Mr. Williams's story online and phoned him. Mr. Williams told Mr. Hutchison he had no "time to get perfect information." Mr. Williams explained his theory of attacking cancer with multiple medicines, saying: "You're going to have to hit it every day with lots of therapies that are relatively low toxicity."

In his loft, Mr. Hutchison re-read several papers highlighting the potential of using high doses of omega-3, a fatty acid found in fish oil, to stop tumor growth. In a magazine, he saw that Mark Puder, assistant professor of surgery at Harvard Medical School, was working with omega-3. He phoned Dr. Puder, who said he had tested the fatty acids in mice with neuroblastoma. The drug didn't extend the mice's lives, but "they looked much better than the other mice," Dr. Puder said.

"If it were your son, would you give him omega-3?" Mr. Hutchison asked. Dr. Puder immediately said yes.

Mr. Hutchison probed for the right dose for his 40-pound son. Dr. Puder said he had no idea, but guessed four to six grams.

These days, Dr. Puder says he devotes two hours each day answering phone calls from patients, many of whom are interested in substances that are still in laboratory testing. Clinical trials are vital to advancing science, he says, but they're slow. "If you have a year to live and there's something in testing that may actually work, why not try it?" he says.

Soon, Mr. Hutchison was gulping down large doses of omega-3. "If I'm going to ask Sam to do this, I have to be willing to do it," he told his wife. Mr. Hutchison swallowed eight large yellow capsules each day.

After taking the omega-3 for two weeks, Mr. Hutchison handed Sam three capsules one morning. Reflecting the intense stress of guesstimating a treatment regimen for one's child, Mr. Hutchison spent that night racing back and forth to his son's room to check on him. He told his wife: "I don't want to be the fool who adds something to the treatment plan that ruins everything."

Creating Sam's treatment regimen consumes much of his father's waking life. Mr. Hutchison sends emails either late at night or early in the morning, arriving at work at 7 a.m. Anxious about his son's illness, Mr. Hutchison phones and emails Sam's doctors so frequently they often joke about it. "I don't think he ever sleeps," Dr. Sholler says.

But the omega-3 seemed to pay off. Within weeks, the Hutchisons say Sam's hair and eyebrows began to grow back and they noticed he had more energy.

Meanwhile, Mr. Hutchison, in frequent touch with other parents online, learned of an extract of a Chinese herb used world-wide to fight malaria that also appears to fight cancer. He discovered that the herb, artemesinin, had been used safely for years. He ordered the medicine on the Internet and began taking five of the pills daily. In January, he added three of the pills to Sam's regimen, upping Sam's daily intake to 20 pills.

Even as Sam's scans were coming back showing the cancerous spots so faint they were barely detectable, Mr. Hutchison continued his hunt, extending his reach to increasingly experimental treatments. James Belanger, a naturopath in Lexington, Mass., and a specialist in finding alternative cancer treatments, cited data from a small clinical trial. He suggested treating Sam with a chemical compound that reduces copper, which tumor cells seem to need to grow. Mr. Hutchison added tetrathiomolybdate, the copper-reducing compound, to Sam's daily treatment.

In October, after the Hutchisons had been shopping for Halloween costumes -- Sam chose the "Incredible Hulk" -- they learned a radiologist's report of his latest scan suggested the cancer might have returned in his right leg. The Hutchisons drove home in silence.

Mr. Hutchison berated himself for not adding more cancer-fighting pills to Sam's daily regimen. He had been digging into research suggesting a mixture of vitamin C and vitamin K3, known as vitamin C:K3, killed cancer cells in a similar way as nifurtimox. He even had ordered boxes of the vitamin mixture and taken it himself, but he had held off giving it to Sam, afraid of adding something new to a drug cocktail that appeared to be effective.

Now, terrified that Sam's cancer was back, Mr. Hutchison added one vitamin C:K3 capsule a day to Sam's treatment regimen.

On a recent afternoon, as Sam sat in front of the television in his living room playing a football game on the computer, Mr. Hutchison interrupted with a box of pills. Pausing the game, Sam downed the pills without hesitation in two gulps of water and resumed play. Soon Sam was exultant.

"I won, I won," he shouted, flashing a big smile and running up the stairs, arms raised.

Then, turning to a visitor, Mr. Hutchison added, softly: "I wish it were that easy in cancer."

Days later, they got good news. The radiologist, re-reading the scan with the Hutchisons, concluded Sam's cancer hadn't returned.

An elated Mr. Hutchison then began questioning his decision to add vitamin C:K3. "I don't want to over-think this thing," he said. But if Sam's cancer wasn't back, he didn't want to risk the vitamin mixture. He decided to stop it until he gets the results of a mouse experiment gauging the effects of vitamin C:K3 with nifurtimox, a test funded by a small foundation Mr. Hutchison and three other parents have launched.

"Playing lab rat with your kid isn't easy," Mr. Hutchison said, tears welling up in his eyes. "This brings me to my knees."

Cancer Cocktails

Below are the combinations of medicines taken by Sam Hutchison, Ben Williams and Donlevy Fitzpatrick to fight terminal cancers. Many doctors oppose this approach of combining anti-cancer agents not yet proven safe and effective, but patients with fatal illnesses argue they have nothing to lose.

* * *

Sam Hutchison's Daily Cocktail

To fight neuroblastoma, Sam's dad put together a cocktail of anti-cancer medicines including these.

Nifurtimox, 360 mg -- Antibiotic used to fight tropical illness, in early clinical trial for cancer
Cytoxan*, 25 mg -- Conventional chemotherapy drug
Tetrathiomolybdate, 80 mg -- Used to treat Wilson's disease, in early testing for cancer
Artemesinin, 150 mg -- Anti-malaria medicine, in early testing for cancer
Omega-3, 4 g -- Used to treat cardiovascular disease, in early testing for cancer
Celebrex, 400 mg -- Anti-inflammatory drug, in testing for cancer

*Cytoxan used two weeks on, one week off

* * *

Ben Williams's Cancer Cocktail

Mr. Williams combined these drugs and other supplements in 1995 to successfully beat his brain tumor.

Tamoxifen, 220 mg daily -- Breast cancer drug, in early testing at the time for brain cancer
Verapamil*, 600 mg daily -- Hypertension drug, believed to make chemotherapy more effective
Accutane**, 160 mg daily -- Severe acne medicine, in early testing at the time for brain cancer
Mushroom extract PSK, 3 g daily -- Used against cancer in Japan
Melatonin, 15 mg/night -- Hormone in trials against cancer in Italy
Conventional chemotherapy

*Verapamil used in the week surrounding chemotherapy
**Accutane used in the weeks between chemotherapy

* * *

Donlevy Fitzpatrick's Cocktail

Mr. Fitzpatrick is currently using this combination to drugs to fight his brain cancer

Avastin+ -- Colorectal cancer drug, effective against brain cancer in combination with Irinotecan in early trials
Irinotecan* -- Conventional chemotherapy drug
Temodar**, 100 mg daily -- Oral chemotherapy drug marketed for brain cancer
Thalidomide, 100 mg daily -- FDA approved for treating multiple myeloma, in early testing for brain tumors
Tarceva, 300 mg daily -- FDA approved for advanced non-small cell lung cancer and as a combination therapy to treat advanced pancreatic cancer, in early trials as a combination therapy for brain cancer

*Avastin and Irinotecan infused every other week
**Temodar given 14 days on, 14 days off treatment

Source: Mr. Hutchison, Mr. Williams and Mrs. Fitzpatrick

Lab Rat?

Cancer Cocktails