A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib With Lomustine to the Efficacy of Lomustine Alone (D8480C00055)
The purpose of this study is to see how effective cediranib is in treating a brain tumour called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents. Cediranib is a new drug that has not yet been approved for this disease. This study will compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo ("inactive substance") to see whether the combination or cediranib alone will be more effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.
Read more! Combo Therapy Shows Promise Against Brain Cancer1/22/2010 12:00:00 AM (MST)
Success in mice with glioblastoma may someday lead to treatment for people, researchers say
Hide Article Combo Therapy Shows Promise Against Brain Cancer1/22/2010 12:00:00 AM (MST)
Combo Therapy Shows Promise Against Brain Cancer
FRIDAY, Jan. 22 (HealthDay News) -- A synthetic form of a naturally occurring hormone combined with chemotherapy inhibited tumor growth and achieved a 25 percent cure rate in mice with a deadly brain cancer called glioblastoma, a new study reports.
Currently, people diagnosed with glioblastoma have a poor prognosis and relatively short life expectancy.
The mice in the study were treated with thymosin alpha 1 (Talpha1/thymalfasin), a synthetic form of the hormone thymosin, produced by the thymus gland.
"Our hypothesis was that the immune system basically needs a boost to kill the cancer cells," Dr. Suzanne de la Monte of Rhode Island Hospital, who led the research, said in a news release from the hospital. "We know that thymosin is currently being used in Europe to treat cancer, so we set out to see what effect this could have on glioblastomas."
When Talpha1 was used alone, the tumor continued to grow. But the researchers found that combining it with chemotherapy produced promising results in the mice.
"We looked at giving chemo plus Talpha1 as a sort of immune booster," de la Monte explained. "What we found is that when you give Talpha1 and the chemo agent together, not only do you have a slower rate of tumor growth with cells being killed, but there have also been cures. We achieved a 25 percent cure rate in these animal models."
The study was published online in the Journal of Oncology.
The researchers said they now want to test the combination treatment in people with glioblastoma.
SOURCE: Rhode Island Hospital, news release, Jan. 18, 2010
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Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing 2 Annual Cycles of IV 12 mg and 24 mg Alemtuzumab to 3x Weekly SC Interferon Beta-1a (Rebif®) in Relapsing-Remitting Multiple Sclerosis Patients Who Have Relapsed on Therapy (CAMMS32400507)
The purpose of this study is to establish the efficacy and safety of two different doses of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with Rebif (interferon beta-1a). The study will enroll patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by MRI. Patients will have monthly laboratory tests and comprehensive testing every 3 months.
Read more! Ampyra Approved for Adults With MS1/22/2010 12:00:00 AM (MST)
Helps those who have trouble walking
Hide Article Ampyra Approved for Adults With MS1/22/2010 12:00:00 AM (MST)
Ampyra Approved for Adults With MS
FRIDAY, Jan. 22 (HealthDay News) -- Dalfampridine (Ampyra) extended-release tablets have been approved by the U.S. Food and Drug Administration to help adults with multiple sclerosis (MS) who have trouble walking.
In clinical testing, people who took Ampyra had faster walking speeds that those who took a placebo, the agency said in a news release.
MS is a chronic, often disabling disease affecting the brain, spinal cord and optic nerves. Some 400,000 people in the United States and 2.5 million globally have been diagnosed with the disease, the FDA said.
The drug, if given at doses higher than the recommended 10 milligrams twice daily, can cause seizures, the agency warned. The most common reported side effects include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, nasal or throat swelling, irregularity, indigestion and burning or itchy skin.
People with moderate-to-severe kidney disease shouldn't take Ampyra, the FDA said.
The drug is marketed in the United States by Hawthorne, N.Y.-based Acorda Therapeutics.
A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects With Partial-onset Seizures (SP904)
This open-label extension trial will assess the long-term use of lacosamide monotherapy and safety of lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).
Read more! Gene Mutation Linked to Fever-Induced Seizures9/18/2009 12:00:00 AM (CST)
Finding could lead to better treatment options, study suggests
Hide Article Gene Mutation Linked to Fever-Induced Seizures9/18/2009 12:00:00 AM (CST)
Gene Mutation Linked to Fever-Induced Seizures
FRIDAY, Sept. 18 (HealthDay News) -- Mutations in a sodium channel gene are associated with fever-induced seizures and a severe form of epilepsy called Dravet syndrome in children 6 months and younger, a new study has found.
American and Dutch researchers studied a large family with a history of febrile seizures and zeroed in on mutations in the SCN9A sodium channel gene. When the mutation was introduced into mice, the rodents had significantly lower thresholds for seizures than those without the mutation. The researchers then confirmed their findings by expanding the study to include people who were not related.
SCN9A is the fifth gene determined to be linked to fever-induced, or febrile, seizures. Previously, the gene had not been suspected to play a role in seizures or epilepsy.
"This gene gives us a much-needed novel target for developing more effective drugs to treat those children with debilitating seizures," the study's first author, Nanda A. Singh, from the genetics department at the University of Utah, said in a news release from the university.
The study appears Sept. 18 in the journal PLoS Genetics.
Febrile seizures, the most common form of early childhood seizures, affect about one in 20 North American infants. Though most infants outgrow the problem, some continue to have seizures into adulthood.
Dravet syndrome is a type of epilepsy that begins with febrile seizures. The researchers said their findings suggest that infants with Dravet syndrome should be tested for the SCN9A mutation to determine whether sodium channel blockers should be used to treat their seizures.
More information
The U.S. National Institute of Neurological Disorders and Stroke has more about febrile seizures.
SOURCE: University of Utah, news release, Sept. 16, 2009
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A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta (IFN-b) Treatment in Multiple Sclerosis Subjects With Active Disease (26593)
The goal of this study is to evaluate the safety, tolerability and effectiveness of oral cladribine when taken in combination with Interferon-beta therapy for the treatment of MS.This study will randomize 200 subjects from approximately 50 sites located world-wide, who have experienced at least one relapse while taking Interferon-beta therapy within 48 weeks prior to Screening, irrespective of disability progression. Secondary progressive multiple sclerosis (SPMS) patients, who are still experiencing relapses, and patients who have received disease modifying drugs (DMDs), other than Interferon-beta therapy, during their MS treatment history, but are currently on Interferon-beta therapy and have experienced active MS symptoms (at least 1 relapse) during the 48 weeks prior to Screening, may also be enrolled.Subjects will be randomised in a 2:1 fashion to receive up to 4 cycles of oral cladribine or matching placebo in combination with Interferon-beta therapy. Total subject participation is 104 weeks.
Read more! Childbirth May Slow Progression of Multiple Sclerosis11/24/2009 12:00:00 AM (MST)
Patients who had at least one child were less likely to become disabled, study finds
Hide Article Childbirth May Slow Progression of Multiple Sclerosis11/24/2009 12:00:00 AM (MST)
Childbirth May Slow Progression of Multiple Sclerosis
TUESDAY, Nov. 24 (HealthDay News) -- Having children may slow the progression of multiple sclerosis, new research suggests.
Belgian researchers followed 330 women who had experienced their first MS symptoms between the ages of 22 and 38.
Women who had given birth to at least one child were 34 percent less likely to have the disease progress to a stage in which they needed walking assistance, such as a cane or brace, than women without children.
While having a baby either before or after the onset of MS symptoms seemed to help, women who had a child after they began experiencing MS symptoms were even better off. During the study, women with MS symptoms who'd had a baby were 39 percent less likely to have their disease progress to the point of needing walking assistance. In the study, women had the disease for an average of 18 years.
"Women with MS who have children seem to have a more benign MS course than those who don't," said study author Marie D'hooghe, of the department of neurology at Nationaal MS Centrum in Melsbroek, Belgium.
The research appears in the Nov. 24 online issue of the Journal of Neurology, Neurosurgery & Psychiatry.
Multiple sclerosis is an autoimmune disease in which the body's own defense system attacks myelin, or the protective fatty substance that surrounds nerve fibers in the central nervous system, according to the National Multiple Sclerosis Society. The damage causes a disruption to nerve signals traveling to and from the brain, which causes the numbness, walking problems, blurry vision and fatigue.
About 85 percent of those with MS start with a relapsing-remitting course, in which attacks are followed by partial or total recovery, according to the study. More than half go on to develop a more progressive form of the disease, in which symptoms worsen over time and there are fewer, shorter periods without symptoms. Eventually, the disease can lead to loss of vision and paralysis.
Women are twice as likely to develop MS as men, though women tend to have less severe cases than men, according to the study.
About three-quarters of the women in the study had children. The researchers measured the time it took for women to reach level 6 on the Expanded Disability Status Scale (EDSS), a rating system used by doctors to describe symptoms, with level 1 being the least severe and 10 being death due to MS. Level 6 is defined as needing a cane, crutch or brace to walk.
Women who did not have children took an average of 13 to 15 years to progress to EDSS 6, while women who had children took an average of 22 to 23 years to reach that stage, the researchers found.
"Having one or more children does seem to be beneficial," said Patricia O'Looney, director of biomedical research for the National Multiple Sclerosis Society. "But we don't know enough about the patient demographics to really draw some major conclusions."
Among the unknowns are the treatments the women in the study were getting for MS or if perhaps the women who decided to have children were feeling better and having fewer symptoms.
Though much remains to be learned about the role of pregnancy in MS, a possible reason why it may help slow the progression of the disease is that during pregnancy, the immune system is "downregulated," in part to prevent the mother's body from rejecting the fetus, O'Looney explained. Suppressing the immune system may also help to control MS, O'Looney noted.
Treatments for MS, such as interferon beta-1a and -1b, work by suppressing the immune system.
A second possibility for why childbirth might help delay the progression of MS is that during pregnancy, estrogen levels rise. Previous research has suggested estrogen may help protect from MS by stimulating the cells that make myelin. The MS Society is currently funding a clinical trial in which women with MS are given estriol, a form of estrogen, along with standard MS treatments.
"The sex hormones do seem to have some neuroprotective role, though we are not quite sure how," O'Looney said.
Still, O'Looney stressed that women should not interpret the results as reason to have a baby to delay the progression of the disease, or blame themselves if they decided not to have children.
"We still don't know a lot about the great variability of MS -- why does one person become more progressive while another follows a more benign course," O'Looney said. "What's certain is that one should not conclude it's based on whether or not you have a child. There are so many other factors, including possibly genetic factors, that determine that."
SOURCES: Marie D'hooghe, department of neurology, Nationaal MS Centrum in Melsbroek, Belgium; Patricia O'Looney, Ph.D., director, biomedical research, National Multiple Sclerosis Society; Nov. 24, 2009, Journal of Neurology, Neurosurgery & Psychiatry, online
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Biobank For MS And Other Demyelinating Diseases (ACP-001)
To establish a large, longitudinal collection of high quality samples and data from subjects with MS, selected other demyelinating diseases (Transverse Myelitis (TM), Neuromyelitis Optica (NMO) or Devic's, Acute Disseminated Encephalomyelitis (ADEM), and Optic Neuritis (ON)), and related and unrelated unaffected controls. Samples and data will be available as a shared resource to scientists researching the causes, sub-types, and biomarkers of MS and related demyelinating diseases.
Read more! Cholesterol Drugs May Slow MS4/16/2010 12:00:00 AM (CST)
Fewer brain lesions developed in patients taking Lipitor than placebo, researchers say
Hide Article Cholesterol Drugs May Slow MS4/16/2010 12:00:00 AM (CST)
Cholesterol Drugs May Slow MS
FRIDAY, April 16 (HealthDay News) -- Cholesterol-lowering statin drugs may slow the progression of multiple sclerosis, according to a new study.
It included 81 patients with early-stage MS randomly selected to take either 80 milligrams a day of Lipitor (atorvastatin) or a placebo. After 12 months of treatment, 55.3 percent of patients taking the drug had developed no new brain lesions, compared with 27.6 percent of those who took the placebo.
The results of the phase II, multi-center trial were presented Wednesday at the annual scientific meeting of the American Academy of Neurology. Lipitor, placebo and additional support were provided by Pfizer, Inc., which makes Lipitor.
"Our data is preliminary, and we need a larger study to confirm the effects of the drug and their magnitude," study co-leader Dr. Emmanuelle Waubant, an associate professor of neurology at the MS Center at the University of California, San Francisco, said in a news release.
"It is important that we understand how statins impact the progression of multiple sclerosis in order to better inform physicians and patients of their effect since these drugs are so broadly used throughout the United States and the world, and to learn whether a relatively inexpensive oral therapy can slow the course of the disease," he added.
MS is an autoimmune disease in which immune cells attack the central nervous system and destroy the protective sheath (myelin) that surrounds nerves. This results in scars or lesions in demyelinated areas of the brain and spinal cord.
More information
The U.S. National Institute of Neurological Disorders and Stroke has more about multiple sclerosis.
SOURCE: University of California, San Francisco, news release, April 14, 2010
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Epilepsy
We are seeking individuals with epilepsy to participate in research studies at St. Joseph's.