http://www.gabrailcancercenter.com/ Specializing in Medical Oncology and HematologySpecializing in Phase I-III Clinical Research Studies en-gb Copyright © 2008 Gabrail Cancer Center [b]Canton Facility:[/b] 4875 Higbee Ave NW, Canton, Ohio 44718Phone: 330-492-3345 Fax: 330-492-0462[b]Dover Facility:[/b] 340 Oxford St, Suite 110, Dover, Ohio 44622Phone: 330-365-2135 Fax: 330-364-9195 Carrie Smith RN - csmith@nospam.com csmith@nospam.com Sat, 04 Sep 2010 18:08:08 -0400 Sat, 04 Sep 2010 18:08:08 -0400 http://backend.userland.com/rss e107 (http://e107.org) 60 http://www.gabrailcancercenter.com/e107_images/e_logo.png http://www.gabrailcancercenter.com/ 88 31 Specializing in Medical Oncology and HematologySpecializing in Phase I-III Clinical Research Studies Search Gabrail Cancer Center query http://www.gabrailcancercenter.com/search.php http://www.gabrailcancercenter.com/news.php?item.18.3 CenterWatch Posting of the Breakthrough Cancer Pain Study. Click below links to find out more:

Canton : Gabrail Cancer Center
Study of Sativex® for Pain Relief in Patients With Advanced Malignancy. (SPRAY study)

Canton : Gabrail Cancer Center
This is a Multicenter, Randomized, Placebo-Controlled research study to evaluate the effectiveness of ARX-F02 (Sublingual Sufentanil NanoTab™) versus placebo ("sugar" pill) in the management of breakthrough pain in cancer patients. The drug being evaluated in this study, Sufentanil has already been approved by the FDA for intravenous (IV) anesthetic use during operative procedures. It has not yet been approved for sublingual (under the tongue) use, which is what this study is evaluating.

Dover : Gabrail Cancer Center
Study of Sativex® for Pain Relief in Patients With Advanced Malignancy. (SPRAY study)
]]> Nang<nsee05@nospam.com> Tue, 22 Sep 2009 11:44:37 -0400 http://www.gabrailcancercenter.com/news.php?item.18.3 http://www.gabrailcancercenter.com/news.php?item.16.3 - Proprietary compounds cross the blood-brain-barrier through novel receptor-based approach -

MONTREAL, CANADA and Denver, CO, April 21, 2009 – AngioChem, a biotechnology company discovering and developing drugs that are uniquely capable of crossing the blood-brain barrier, today presented promising new safety, tolerability and preliminary efficacy data for its lead drug candidate, ANG1005, from two separate Phase 1/2 studies in patients with recurrent malignant glioma and in patients with advanced solid tumors and brain metastases. The data demonstrated that ANG1005 has potential efficacy as evidenced by tumor regression and the halting of tumor progression; has a favorable safety and tolerability profile; and has the ability to cross the blood-brain barrier toeffectively deliver active therapeutic concentrations. These data were presented at the annual meeting of the American Association for Cancer Research (AACR), being held in Denver, Colorado, from April 18-22, 2009.

Primary (glioma) and secondary (metastases from other solid tumors) brain cancers are highly aggressive and fatal cancers that affect approximately 200,000 patients annually in the United States. Treatment options for brain cancer patients are limited and prognoses are dismal due to the effective role the blood-brain barrier (BBB) serves as the natural guardian of the brain, preventing more than 95 percent of drugs from reaching the brain. AngioChem, leveraging its proprietary Engineered Peptide Compound (EPiC) platform, is developing ANG1005 as its first clinical compound within a deep and broad pipeline of product candidates uniquely capable of crossing the BBB to treat a wide range of brain diseases.

“We are very excited by the encouraging tumor responses ANG1005 has produced in a trial that was designed primarily to assess safety and tolerability,” said Jean-Paul Castaigne, M.D., President and Chief Executive Officer of Angiochem. “While we recognize that this is a study on a relatively small population of patients, these encouraging tumor responses support our belief that ANG1005 has the unique ability to successfully cross the BBB and has the remarkable potential to treat brain cancers in a completely new way. We look forward to receiving the final data and, with the right partner, initiating a larger and possibly pivotal clinical trial early next year to further explore the potential of ANG1005.”

ANG1005, a novel taxane derivative, is currently being evaluated in two separate Phase 1/2 multicenter, open-label, dose escalation studies to explore the maximum tolerated dose and obtain data on safety, tolerability and preliminary evidence of efficacy in patients with recurrent malignant glioma and in patients with advanced solid tumors and brain metastases.

AngioChem presented preliminary data from these two studies based on available data from 32 patients in the malignant glioma study and 42 patients in the advanced solidtumor and brain metastases study. Enrollment in these studies continues. Key findings from the data from these patients, presented at AACR, include:

• Tumor response data, as measured by magnetic resonance imaging (MRI) or computerized tomography ( CT), show that ANG1005 has potential efficacy as evidenced by tumor regression and the halting of tumor progression;

• In the seven advanced solid tumor patients with brain metastases who received ANG1005 at a dose of >300mg/m^2 , five patients experienced a response, including one partial response, two minorresponses and two had their disease stabilize;



• In the 22 malignant glioma patients who received ANG1005 at sixsub-therapeutic dose levels evaluated to date, seven patients experienced a response at this preliminary analysis, while dose escalation continues;

• Safety and tolerability data show that adverse events from treatment with ANG1005 were manageable and less severe than those engendered by paclitaxel in comparable dosages and included neutropenia, leucopenia, thrombocytopenia and anemia;

• Immunogenicity data, as measured by Enzyme-Linked ImmunoSorbent Assays(ELISA), show that ANG1005 does not elicit an immune response, including in patients who have received up to six treatment cycles;

• Neurocognitive data show that ANG1005 does not show evidence of central nervous system toxicity;

• One patient with advanced solid tumors with brain metastases, whoachieved a minor response, showed significant improvement in memory, processing speed and executive function after six, 12 and 24 weeks oftherapy.

• Tumor sample data show that the active therapeutic concentration of ANG1005was approximately 20 times greater than that of paclitaxel, as measured in theparenchyma of a tumor sample that was collected from a patient after receipt of asingle 200mg/m 2 dose of ANG1005 and preliminary data from a second tumor sample and different patient confirms this trend.

About AngioChemAngioChem is a clinical-stage biotechnology company discovering and developing new breakthrough drugs that are uniquely capable of crossing the blood-brain barrier to treat brain diseases. These new Engineered Peptide Compounds (EPiC) have the potential toaddress significant medical needs, many of which cannot be effectively addressed due to the fundamental physiological challenge the blood-brain barrier presents fortherapeutic intervention. AngioChem’s lead product candidate, ANG1005, is in two separate Phase 1/2 clinical studies in patients with primary brain cancers and in cancer metastases. Additionally, AngioChem is developing a deep and broad product pipeline, including small and large molecules, for the treatment of a wide range of brain diseasesand related disorders, including brain cancer, cancer metastases, neurodegenerative and metabolic diseases. Founded in 2006, AngioChem maintains headquarters in Montreal, Canada. For additional information about the Company, please visit http://www.angiochem.com.]]> http://www.gabrailcancercenter.com/comment.php?comment.news.16 Nang<nsee05@nospam.com> Fri, 04 Sep 2009 11:22:02 -0400 http://www.gabrailcancercenter.com/news.php?item.16.3 http://www.gabrailcancercenter.com/news.php?item.13.3 By GINA KOLATA
New York Times


Not long ago, at a meeting of an advisory group established by Congress to monitor the war on cancer, participants were asked how to speed progress.

“Everyone was talking about expanding the cancer work force and getting people to stop smoking,” said Dr. Scott Ramsey, a cancer researcher and health economist, who was participating in that January 2008 meeting of the President’s Cancer Panel. “Lots of murmurs of approval.”

Then it was his turn.

The biggest barrier, in his opinion, was that almost no adult cancer patients — just 3 percent — participate in studies of cancer treatments, mostly new drugs or drug regimens.

“To me it was obvious,” Dr. Ramsey said. “We can’t improve survival unless we test new treatments against established ones.”

The room fell silent.

“It was one of those embarrassing moments,” said Dr. Ramsey, an associate professor at the Fred Hutchinson Cancer Center in Seattle. He had brought up the subject he said no one wanted to touch.

Forty years after President Richard M. Nixon declared war on cancer, death rates have barely changed. “Why aren’t we getting cures?” Dr. Ramsey said. “This is one of the biggest reasons.”

Of course, there have been highly successful clinical trials — studies of drugs like Gleevec for chronic myelogenous leukemia and estrogen-blocking therapy for breast cancer, and also studies that proved drugs did not work. But the problem is still immense, cancer researchers agree.

There are more than 6,500 cancer clinical trials seeking adult patients, according to clinicaltrials.gov, a trials registry. But many will be abandoned along the way. More than one trial in five sponsored by the National Cancer Institute failed to enroll a single subject, and only half reached the minimum needed for a meaningful result, Dr. Ramsey and his colleague John Scoggins reported in an editorial in the September 2008 issue of The Oncologist.

Even worse, many that do get under way are pretty much useless, even as they suck up the few patients willing to participate. These trials tend to be small ones, at single medical centers. They may be aimed at polishing a doctor’s résumé or making a center seem at the vanguard of cancer care. But they are designed only to be “exploratory,” meaning that there are too few patients to draw conclusions or that their design is less than rigorous.

“Unfortunately, many patients who are well intentioned are in trials that really don’t advance the field very much,” said Dr. Richard Schilsky, an oncologist at the University of Chicago and immediate past president of the American Society of Clinical Oncology.

Others studies, by companies, are designed to persuade doctors to use their drugs.

Still others are testing questions like whether it makes a difference to give a drug every nine days or every two weeks. “These are practical real-world questions,” Dr. Schilsky said. “But they don’t do a great deal to advance the research field. They are not going to provide the next breakthrough.”

In any case, the great majority of oncologists just steer clear of studies. They make little or nothing on trials and, in fact, often lose money. These doctors also may discourage patients from going elsewhere to enter a trial: if a patient leaves, the doctor loses business.

One issue is the money lost on chemotherapy, the source of 60 percent to 80 percent of the revenue at oncologists’ offices. The doctors buy the drugs and are reimbursed by insurance for slightly more than the drugs’ cost. But if patients are in clinical trials, the drugs may be paid for by the federal government or a drug company sponsoring the study — and doctors get nothing.

Then there is the poorly reimbursed hour or so it takes to explain a trial to prospective patients. And, after all that, most patients either turn down the trials or, after further testing, turn out to be unqualified.

That is just the start, cancer specialists say. There is voluminous paperwork. And the risk of legal liability for errors like neglecting to mention a financial interest in the drug being tested, in specimen handling or in billing.

“A lot of doctors say, ‘This is not worth it,’ ” Dr. Schilsky said.

Reluctant Patients

It is one of the worst times imaginable — a cancer diagnosis, all the terror that goes with it, and then, sitting in a doctor’s office and being asked to make difficult decisions about treatment. Then add questions about joining a trial. Some say it is just too much to think about.

Research starts with so-called Phase 1 trials that test a drug’s safety and the maximum dose patients can tolerate. Although it is possible that some will benefit, most do not because the doses are ineffective or unsafe and few new drugs prove worthwhile.

Then comes Phase 2, further testing of the drug in a small study, and Phase 3, in which patients with a particular cancer that is still treatable are randomly assigned to get the best available current drug or that drug plus the new experimental one.

Most patients are not interested in clinical trials. Some do not want the extra office visits and tests a trial entails and do not want their treatment determined by the flip of a coin. Others fear getting a placebo, even if there isn’t one — placebos are rarely used in United States cancer trials. Others find the whole idea too overwhelming when they are trying to save their lives.

At California Cancer Care, in Greenbrae, north of San Francisco, where Dr. Peter Eisenberg works, the agony of choosing a trial was on display. Although the oncologists there try to offer trials to every patient, last year they enrolled just 43 of about 700 new patients.

The most enthusiastic have lethal tumors and no effective treatments, Dr. Eisenberg explained. They are like one of his patients, Ken Fye, a retired rheumatologist with pancreatic cancer who hopes to find a study in which he can enroll. He figures he has little to lose and wants to help science. “It would be obscene if I did not,” he said.

It is not entirely clear why some trials succeed, but researchers say those that do may have some features in common: patients may be like Dr. Fye, with no or few options, so they are easier to recruit, particularly if the drug promises to make a real difference, not just give them a few days or weeks. Successful trials also typically address an important problem, as opposed to a more marginal one, and involve experienced investigators and patient advocates who push for participation.

But it can be particularly hard to recruit patients whose prognosis is better.

Gael Casner, for instance, turned down a trial that would have required her to see Dr. Eisenberg for weekly infusions of a cancer drug, Avastin, that was being tested. It had helped women with breast cancer that was more advanced than her own.

For Ms. Casner, a 57-year-old college admissions adviser, the prospects, after surgery and chemotherapy, were excellent. “I was thinking, ‘O.K., I hate shots,’ ” she said. And she has to travel for her job, making it difficult to go in once a week for an infusion.

“If they had said every month, I would do it,” Ms. Casner said. “But every week was a deal breaker. That was why, personally, for me, the trial did not make sense. I was not in a life-threatening situation.”

Then there are the patients for whom there is still a real risk of a recurrence but who are not prepared to cope with a clinical trial on top of everything else. Those are like Dr. Eisenberg’s first patient on one bright June morning, a 74-year-old man accustomed to danger — he flew helicopters for the military — now facing a very different kind of risk for which he felt unprepared.

The man, who asked that his name not be used to protect his privacy, sat grim and ashen in a sunny exam room, his wife at his side, his daughter across from him. He had colon cancer. It had already invaded his lymph nodes and eaten through the wall of his bowel. He had had surgery and now had to decide what, if anything, to do next.

Choice No. 1: no chemotherapy, no further treatment. Thirty-one of 100 patients like him who chose no further treatment were alive and cancer-free for at least five years. But 30 of 100 relapsed, and 39 died of other causes, like a heart attack.

Choice No. 2: the most aggressive chemotherapy, including 48-hour intravenous infusions of a drug with serious side effects. If he chose that regimen, he would have a 43 percent chance of being alive and cancer-free in five years. But he also had a 14 percent chance of relapsing. And he had a 44 percent chance of dying of something else.

The bottom line, Dr. Eisenberg said, is that 11 people of 100 who get this chemotherapy are alive and well because of it. But that also means that almost 9 of 10 who opt for this treatment are not helped — they either relapse or die of other causes within five years.

Choice No. 3: a less aggressive chemotherapy with a smaller improvement in survival rate.

But there was another option. He could join a Phase 3 clinical trial sponsored by a drug company, ImClone. He would be randomly assigned to receive chemotherapy with or without ImClone’s drug, Erbitux, approved for people with colon cancer more advanced than his. The aim was to find out whether Erbitux could also help those with earlier colon cancer.

“The trial may help you or it may hurt you because the drug may make you sick,” Dr. Eisenberg said.

“I know this is overwhelming,” he added.

“I’ve been overwhelmed for three months,” the man replied.

The 45-minute conversation over, the man, shaken, went home to ponder his options.

A week later he was back. He wanted chemotherapy, but a clinical trial was not for him. He joined the majority of cancer patients, hoping for the best with what is already known.

Reluctant Doctors

For 15 years, Dr. John M. Rainey at Louisiana Oncology Associates in Lafayette did his best to enroll patients in clinical trials. He believed in research and thought doctors like him should do their part. But he finally had to stop. Every study was costing his group a few hundred dollars to $1,500 and the bureaucratic requirements were getting out of control.

“When we put a pencil to it, it didn’t make economic sense,” Dr. Rainey said.

First was the institutional review board, the committee that reviews the trial to make sure patients are protected from harm. Every time a study patient had an adverse reaction, every participating medical center had to notify patients and respond to the review board. Many reactions had nothing to do with the drugs, Dr. Rainey said, and instead were related to the patients’ illnesses.

“It became a hassle factor,” he said. “We didn’t have the manpower.” One of the five doctors in the group was spending three to five hours a week filling out forms.

“You could see five or six or seven patients in that time,” Dr. Rainey said.

Then there was the unreimbursed or poorly reimbursed time to explain a clinical trial to patients and get consent. Those who agreed would have to come back a second time to start treatment, adding to the patients’ costs as well, since most lived 25 to 50 miles away. If they were not in a study, their treatment could start right away.

“We were seeing more and more patients, and time did not allow us to sit down with patients and get them on trials,” Dr. Rainey said.

“It just did not make economic sense for us to go in the hole,” Dr. Rainey explained.

And that, researchers say, is one reason why progress is so slow.

Only one study in five even publishes its results, Dr. Ramsey and Dr. Scoggins found.

And, of the unpublished studies, “a significant percentage” probably ended uncompleted because they could not recruit enough patients, noted Dr. Gregory A. Curt and Dr. Bruce A. Chabner, editors of the journal The Oncologist, in an editorial on Dr. Ramsey’s and Dr. Scoggins’s paper. “Which potential statistic is the sadder, the low publication rate” or, Drs. Curt and Chabner wrote in The Oncologist, the meager number of patients who enroll?

“In truth they both are,” the two oncologists continued, “as neither should be true.”

A New Approach

Cancer experts offer two answers to the problem of clinical trials: spend more, giving doctors better incentives and perhaps even paying patients, or, with no real prospects for a big infusion of money, use available money and patients more efficiently.

Donald Berry, a statistician at the M.D. Anderson Cancer Center in Houston, wants to use resources more efficiently. To do so, he designed a new sort of study to test experimental drugs for breast cancer.

The study, starting this fall, is a departure from traditional notions of drug testing and cancer treatment.

Participants will be women who are newly diagnosed with breast cancer and at high risk that it will spread in their bodies.

Ordinarily, women with breast cancer have surgery first to remove the tumor in their breast and then have chemotherapy. The problem with removing the tumor right away is that it can take 5 to 10 years to know whether an experimental drug killed any remaining cancer cells. It is easier and much faster to assess an experimental drug’s effects on tumors that remain in the body. So in this study, women will get standard chemotherapy and experimental drugs first. Researchers will do MRI scans to see whether the tumors are responding.

Then, six months later, surgeons will remove the tumor or, if the tumor is gone, tissue from where it used to be, to determine how the cancer responded to the drugs.

The idea of leaving a cancer in place for six months can sound shocking, even dangerous. But cancer researchers say it actually makes no difference whether chemotherapy comes before or after surgery.

“If a woman comes in with a large tumor, surgery isn’t going to save her life,” said Dr. Laura Esserman, a breast surgeon at the University of California, San Francisco, who is principal investigator for the study. Death is caused by cancer that spreads beyond the breast.

“The standard way,” Dr. Esserman added, “operate, give a drug, hope for the best, is not going to work if you are trying to drive progress quickly.”

Also, this study will analyze the genetic makeup of the patient’s tumor and use that information to determine which drugs might be most effective. In most studies researchers have not accounted for genetic differences in tumors.

The study will also ensure that women have a better chance of getting whatever drug seems to be working. As the study goes on, if one drug appears to be working better than others, researchers will adjust the study so that new participants whose tumors have the same genetic makeup will be more likely to get it.

The aim is to need far fewer women to determine whether a drug works, and to get answers more quickly.

Dr. Berry said that some traditional breast cancer trials are seeking 5,000 or even 10,000 women. It is no surprise, he added, that trials start “limping along” trying to enroll their quotas of patients.

In the new study, the winners of this drug competition will be tested in a definitive Phase 3 study with just 300 patients whose tumors have a similar genetic profile to those of the women who responded.

“This is definitely the answer” to the problem of getting enough patients for studies, Dr. Berry said. “We will use patients more wisely.”

This article has been revised to reflect the following correction:

Correction: August 5, 2009
An article on Monday about the shortage of volunteers for clinical trials in cancer research misstated the source of a finding that more than one trial in five sponsored by the National Cancer Institute failed to enroll a single subject, and only half reached the minimum needed for a meaningful result. It came from an editorial in the September 2008 issue of The Oncologist, not from a review in that issue.]]> Nang<nsee05@nospam.com> Wed, 26 Aug 2009 15:03:22 -0400 http://www.gabrailcancercenter.com/news.php?item.13.3 http://www.gabrailcancercenter.com/news.php?item.11.3 Excellence in Cancer Treatment in your Backyard... 

December 2008 

Local oncologist tapped for consultant job with FDA  

Canton, OH

Dr. Nash Gabrail, an oncologist at Gabrail Cancer Center (GCC), has reached another milestone in furthering the development of cancer care. Dr. Gabrail was actively sought by the Food and Drug Administration (FDA) and offered a position as a Special Government Employee (SGE) for the Center for Drug Evaluation and Research (CDER) program. He was chosen for this prestigious position based on his abilities, experience, and academic orientation while practicing community oncology. He is recognized by national leaders in the field who recommended him to the FDA. Dr. Gabrail has been a pioneer in moving quality clinical research into the community and successfully making innovative clinical trials available in areas relatively remote from academic institutions. His abilities and success in the design and review of pivotal clinical trials sponsored by the pharmaceutical industry have been widely recognized and increasingly sought by everyone involved in the process of new drug development. In this new capacity, Dr. Gabrail will be responsible for reviewing data on clinical trials done on experimental agents that are under consideration for approval by the FDA. In addition to the critique of the submitted trials, Dr. Gabrail will have voting rights on whether the agents in question are to be recommended for approval or not by the government agency. Of course, Dr. Gabrail will continue to practice in the same capacity as he has been over the past 19 years. The SGE position is consultation that will not affect his dedication to his patients. In fact, this position will enhance his ability to bring new, state-of-the-art cancer therapies to the public.   

]]> Carrie Smith<webmaster@nospam.com> Wed, 07 Jan 2009 23:45:24 -0500 http://www.gabrailcancercenter.com/news.php?item.11.3