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! Childhood Cancer Survivors Face Health Problems Throughout Life5/24/2010 12:00:00 AM (CST)
More likely to struggle with medical issues as adults, analysis finds
Hide Article Childhood Cancer Survivors Face Health Problems Throughout Life5/24/2010 12:00:00 AM (CST)
Childhood Cancer Survivors Face Health Problems Throughout Life
MONDAY, May 24 (HealthDay News) -- A new analysis of childhood cancer survivors finds they are more likely to suffer from medical problems and other health challenges as adults.
Emily Dowling, of the U.S. National Cancer Institute, and colleagues studied findings from over 295,000 interviews in the National Health Interview Survey from the last few years. Of those interviews, 410 were with adult survivors of childhood cancer.
The researchers found that childhood cancer survivors were more likely than other adults to say their health is only fair or poor (24 percent compared to 11 percent), more likely to say their health was limited (13 percent compared to 3 percent), more likely to be unable to work because of medical problems (21 percent compared to 6 percent) and more likely to be limited by their health in terms of the work they could do (31 percent compared to 11 percent).
The survey also found that childhood cancer survivors missed an average of 69.3 days of work in the past year due to health problems, according to the report in the May 24 online edition of Cancer.
"Our study suggests that adult survivors of childhood cancer deserve special medical attention and may benefit from interventions to improve their health and productivity," Dowling said in a news release from the American Cancer Society.
More information
The U.S. National Library of Medicine has more on childhood cancer.
SOURCE: American Cancer Society, news release, May 24, 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! Added Drug Aids MS Treatment2/16/2010 12:00:00 AM (MST)
Multi-center study shows daclizumab reduces disease activity when added to interferon beta
Hide Article Added Drug Aids MS Treatment2/16/2010 12:00:00 AM (MST)
Added Drug Aids MS Treatment
TUESDAY, Feb. 16 (HealthDay News) -- Adding the drug daclizumab to standard treatment with interferon beta may reduce multiple sclerosis disease activity more than interferon beta alone, a new study reports.
Previous non-randomized studies found that daclizumab -- a humanized monoclonal antibody -- reduced MS disease activity.
This new phase 2 study at 51 centers in the United States, Canada, Germany, Italy and Spain included 230 patients with active relapsing MS who were taking interferon beta. They were randomly selected to also receive either high-dose daclizumab (2 milligrams/kilogram every two weeks), low-dose daclizumab (1 milligram/kilogram every four weeks) or an inactive placebo. The combined treatments continued for 24 weeks.
MRI scans of the patients' brains were taken every four weeks between weeks 8 and 24 of the study in order to determine the number of new or enlarged gadolinium contrast-enhancing lesions, which indicate MS disease activity.
By the end of the study, the adjusted mean number of new or enlarged gadolinium contrast-enhancing lesions was 1.32 in the high-dose group (75 patients), 3.58 in the low-dose group (78 patients) and 4.75 in the placebo group (77 patients).
Levels of CD56bright natural killer cells were seven to eight times higher in patients taking daclizumab than in those taking the placebo.
"This study provides confirmatory data that daclizumab treatment causes an expansion of CD56bright natural killer cells and adds support to the theory that expansion of CD56bright natural killer cells might mediate some of the effects of daclizumab on reducing multiple sclerosis lesion activity. In addition to the results of previous trials of daclizumab in multiple sclerosis, several lines of evidence have suggested a potential immunoregulatory function for CD56bright natural killer cells: they are expanded during conditions of natural immune tolerance, for example, pregnancy," the researchers from the Neurovirology Research Laboratory at the VA Medical Center in Salt Lake City, and the University of Utah, reported in a news release.
"This randomized controlled trial indicates that daclizumab can reduce new lesion formation in relapsing multiple sclerosis compared with interferon-beta alone," the researchers concluded. "Multiple sclerosis treatments that have the potential to improve in risk-benefit ratios when compared with available treatments are needed; thus, additional studies to define the long-term clinical risks and benefits of daclizumab are warranted."
The study was released online Feb. 15 in advance of publication in the April issue of The Lancet Neurology.
More information
The U.S. National Institute of Neurological Disorders and Stroke has more about multiple sclerosis.
SOURCE: The Lancet Neurology, news release, Feb. 15, 2010
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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! Children With Epilepsy Feel on Par With Healthy Siblings5/24/2010 12:00:00 AM (CST)
Parents disagree, may underestimate their quality of life, researchers say
Hide Article Children With Epilepsy Feel on Par With Healthy Siblings5/24/2010 12:00:00 AM (CST)
Children With Epilepsy Feel on Par With Healthy Siblings
MONDAY, May 24 (HealthDay News) --Children with epilepsy view their quality of life as being as good as that of their healthy siblings, a new study reveals.
The finding suggests that despite the numerous challenges they face in the form of seizures, cognitive and learning disadvantages, social stigma and the effects of medication, children with epilepsy have a far more positive take on their well-being than their parents have.
The study is the result of research conducted by scientists at the University of California, Los Angeles, and led by Dr. Christine Bower Baca, a clinical instructor in UCLA's department of neurology.
About 3 million Americans have epilepsy, the study authors wrote, and approximately 45,000 children below the age of 15 develop the condition each year. Causes for childhood epilepsy vary, and can include problems during delivery, quirks in prenatal brain development, head trauma, tumors, genetics, brain infection and prolonged seizures linked to fever.
To gain insight into how the children with epilepsy viewed themselves, the research team interviewed 143 children with epilepsy (matching each one to a sibling without epilepsy) and their parents.
Interviews were conducted eight to nine years following a diagnosis of epilepsy. Among the children with the condition who were assessed, the average age was 12.
In terms of ranking such quality of life variables as behavior, general health, self-esteem and physical function, Baca and her colleagues found that parents rated their child with epilepsy much lower than their healthy child.
Children with epilepsy, in contrast, felt they were on par with their healthy siblings.
"In this regard, parental perception of their epileptic child may be distorted because of their perception that they have a child that is 'sick,'" Baca said in a news release. "Such a distortion could lead to an underestimate of the child's quality of life."
Noting that children and parents may not always share the same concerns, Baca added that children and parents "may draw on different values and perspectives to evaluate quality of life" without realizing it. Getting a handle on these critical differences in perspectives, she said, could be helpful down the road when designing support services for children as they enter adulthood.
Baca and her team reported the findings online in Value in Health.
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! 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.
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! 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.
