Nci clinical trial 13649




















January 6, —Researchers with a study conducted at NCI, the National Institute for Allergy and Infectious Diseases, and the National Human Genome Research Institute, discovered genetic mutations that may contribute to the development of an aggressive form of non-Hodgkin lymphoma. These findings provided insight into a mechanism that cancer cells may use to survive, thus identifying potential new targets for treatment of the disease.

January 19, —Researchers found that the most common form of malignant brain cancer in adults, glioblastoma multiforme, is not a single disease but appears to be four distinct molecular subtypes that respond to aggressive chemotherapy and radiation differently, according to a study by The Cancer Genome Atlas Research Network.

April 19, —Long-term results show that Raloxifene, a common osteoporosis drug, prevented breast cancer to the same degree, but with fewer serious side-effects than the drug Tamoxifen that had been in use many years for breast cancer prevention as well as treatment.

In particular, there was significantly less endometrial cancer with raloxifene use. November 10, —Researchers discovered mutations in a particular gene that affects the treatment prognosis for some patients with acute myeloid leukemia, an aggressive blood cancer that kills 9, Americans annually. December 23, —NCI announced major changes to the long-established Clinical Trials Cooperative Group Program that conducts many of the nationwide trials of new cancer therapies.

In a major transformation, NCI intends to consolidate the nine groups that currently conduct trials in adult cancer patients into four state-of-the-art entities that will design and perform improved trials of cancer therapies.

The changes are designed to provide greater benefits for cancer patients and more information for researchers. These moves come in response to an NCI-requested April report from the Institute of Medicine, which called for a series of changes to the cooperative groups program, including restructuring.

The NCI Cooperative Group program, founded over 50 years ago, involves more than 3, institutions and 14, investigators, and the program enrolls over 25, patients in clinical trials each year. March 10, —The number of cancer survivors in the United States increased to There were 3 million cancer survivors in and 9. March 31, —Rates of death in the United States from all cancers for men and women continued to decline between and , the most recent reporting period available, according to the latest Annual Report to the Nation on the Status of Cancer.

June 5, —NCI announced clinical trial results showing that in a high-risk form of pediatric acute lymphoblastic leukemia, a high-dose schedule of a drug raises already high cure rates even higher. June 29, —An analysis of genomic changes in ovarian cancer has provided the most comprehensive and integrated view of cancer genes for any cancer type to date. TCGA researchers completed whole-exome sequencing, which examines the protein-coding regions of the genome, on an unprecedented tumors.

Two doses of the human papillomavirus vaccine HPV Cervarix were as effective as the current standard three-dose regimen after four years of follow-up. January 19, —A clinical trial has shown that addition of chemotherapy to radiation therapy leads to a near doubling of median survival time in patients with a form of brain tumor oligodendroglioma that carries a chromosomal abnormality called the 1p19q co-deletion.

Federal government scientists reported that heavy exposure to diesel exhaust increased risk of death from lung cancer. March 8, —In a new examination of United States cancer incidence data, investigators reported that incidence trends have remained roughly constant for glioma, the main type of brain cancer hypothesized to be related to cell phone use.

September 27, —Scientists may have discovered why a protein called MYC can provoke a variety of cancers. Like many proteins associated with cancer, MYC helps regulate cell growth.

A study carried out by researchers at NIH and colleagues found that, unlike many other cell growth regulators, MYC does not turn genes on or off, but instead boosts the expression of genes that are already turned on. More than 30 percent of all human cancers are driven by mutations of the RAS family of genes.

This approach is called a "hub and spoke" model. September 19, —A world-wide competition to bring emerging breast cancer technologies to market was launched by the Avon Foundation for Women, in partnership with NCI and the Center for Advancing Innovation.

Teams were offered the opportunity to create strategic business plans and the potential to start new companies based on the development of 10 unlicensed breast cancer inventions by turning them into commercially marketed products. Breast cancer inventions include therapeutics, diagnostics, prognostics, one device, one vaccine, and a health IT invention, all from the NCI intramural Center for Cancer Research and Avon Foundation-funded university labs.

In a new, complementary report, TCGA experts examined more than GBM samples—the largest to date utilizing genomic characterization techniques and nearly more than were examined in —to identify several additional significantly mutated genes in GBM.

November 13, —A trial conducted by researchers at NCI showed adult patients with a type of cancer known as Burkitt lymphoma had excellent long-term survival rates—upwards of 90 percent—following treatment with low-intensity chemotherapy regimens.

Standard treatment for Burkitt lymphoma involves high-dose chemotherapy, which has a high rate of toxicity, including death, and cures only 60 percent of adult patients.

November 20, —NCI scientists report that the incidence of oropharyngeal cancer significantly increased during the period among people in countries that are economically developed. Recent studies from several countries have reported rising incidence of oropharyngeal cancers and subsequent studies have shown the human papilloma virus HPV as the potential cause.

Researchers note that prophylactic HPV vaccine has been shown to protect against oral HPV infection, suggesting an additional benefit of vaccination programs for both women and men. Recent advances in deciphering the cancer genome have enabled the development of targeted therapies. To explore targeted therapies, cancer clinical trials need to screen large numbers of patients with the same or different histologic tumor types to identify those patients whose tumors contain the distinct molecular targets of the therapies being tested.

March 5, — Ten winners of a world-wide competition to bring emerging breast cancer research technologies to market faster were announced today by the Avon Foundation for Women, in partnership with the NCI, and the Center for Advancing Innovation CAI. ALCHEMIST represents three integrated, precision medicine trials that are designed to identify people with early-stage lung cancer who have tumors that harbor EGFR and ALK gene alterations and evaluate whether drug treatments targeted against those molecular changes can lead to improved survival compared to current standard of care therapy alone e.

August 30, —In a large international collaborative analysis of risk factors for non-Hodgkin lymphoma NHL , NCI scientists were able to quantify risk associated with medical history, lifestyle factors, family history of blood or lymph-borne cancers, and occupation for 11 different NHL subtypes, including less common subtypes. These findings provide crucial insight into the diverse factors that drive different NHL subtypes and correspond with their biological and clinical characteristics.

The honorees received their medals at a White House ceremony later in as recognition for their outstanding contributions to discoveries that enabled the development of HPV vaccines. NCORP is a national network of investigators, cancer care providers, academic institutions, and other organizations. NCORP conducts multi-site cancer clinical trials and studies in diverse populations in community-based healthcare systems across the United States and Puerto Rico with a goal of NCORP bringing cancer clinical trials and cancer care delivery research to individuals in their own communities.

Researchers at NCI intend to use this approach to find new, more effective treatments for various kinds of cancer based on increased knowledge of the genetics and biology of the disease and scientists hope to apply precision medicine to all areas of health and healthcare.

January 27, —In the largest prospective study to date of image-guided technology for identifying suspicious regions of the prostate to biopsy, NCI researchers compared the ability of this technology to detect high-risk prostate cancer with that of the current standard of unguided prostate biopsy.

April 20, —A new NCI study shows that inherited variations in a known tumor suppressor gene among children and adolescents with osteosarcoma, a cancer of the bone, are more common than previously thought. Older patients who are also susceptible to this malignancy were not found to carry mutations in the gene, known as TP August 13, —Using novel large-scale imaging technology, NCI intramural researchers announced they have mapped the spatial location of individual genes in the nucleus of human cells and identified 50 cellular factors required for the proper three-dimensional 3D positioning of genes.

These spatial locations play important roles in gene expression, DNA repair, genome stability, and other cellular activities. The goal is to double the rate of progress against cancer, achieving in five years what otherwise would have taken ten. May 16, —NCI scientists found that leisure-time physical activity was associated with lower risks of 13 cancer types esophageal adenocarcinoma, liver, lung, kidney, gastric cardia, endometrial, myeloid leukemia, myeloma, colon, head and neck, rectal, bladder, and breast.

Most of these associations were evident regardless of body mass index or smoking history. These findings confirm and extend the evidence for a benefit of physical activity on cancer risk and support its role as a key component of population-wide cancer prevention. This data sharing platform promotes precision medicine in oncology. It is an expandable knowledge network supporting the import and standardization of genomic and clinical data from cancer research programs.

As more researchers add clinical and genomic data to the GDC, it will become an even more powerful tool for making discoveries about the molecular basis of cancer that may lead to better care for patients. December 7, — In a study of an immune therapy for colorectal cancer that involved a single patient, researchers identified a method for targeting the cancer-causing protein produced by a mutant form of the KRAS gene. December 28, —In an early-phase intramural clinical trial of a new oral drug, selumetinib, children with the common genetic disorder neurofibromatosis type 1 NF1 and plexiform neurofibromas, tumors of the peripheral nerves, tolerated selumetinib and, in most cases, responded to it with tumor shrinkage.

At present, no therapies are considered effective for NF1-related large plexiform neurofibromas, but, in this trial, partial responses, meaning 20 percent or more reduction in tumor volume, were observed in over 70 percent of the patients.

NF1 affects 1 in 3, people. February 4, —Senator M. Neely, West Virginia, introduced Senate Bill to authorize a reward for the discovery of a successful cure for cancer. March 7, —Senator M. Neely introduced Senate Bill to authorize the National Academy of Sciences to investigate the means and methods for affording Federal aid in discovering a cure for cancer and for other purposes.

April 23, —Senator W. Harris, Georgia, introduced Senate Bill to authorize the Public Health Service and the National Academy of Sciences jointly to investigate the means and methods for affording Federal aid in discovering a cure for cancer and for other purposes.

April 2, —Senator Homer T. April 29, —Congressman Maury Maverick, Texas, introduced House Resolution to promote research in the cause, prevention, and methods of diagnosis and treatment of cancer, to provide better facilities for the diagnosis and treatment of cancer, to establish a National Cancer Center in the Public Health Service, and for other purposes.

The bill also calls upon NCI to assist and promote similar research at other public and private institutions. March 28, —House Joint Resolution , 75th Congress, was passed, "To dedicate the month of April in each year to a voluntary national program for the control of cancer.

December 23, —The National Cancer Act of provides increased authorities and responsibilities for the NCI Director; initiating a National Cancer Program; establishing a 3-member President's Cancer Panel and a member National Cancer Advisory Board, the latter replacing the National Advisory Cancer Council; authorizing the establishment of 15 new research, training, and demonstration cancer centers; establishing cancer control programs as necessary for cooperation with state and other health agencies in the diagnosis, prevention, and treatment of cancer; and providing for the collection, analysis, and dissemination of all data useful in the diagnosis, prevention, and treatment of cancer, including the establishment of an international cancer data research bank.

November 9, —The Community Mental Health Centers Act amends the National Cancer Act to emphasize education and demonstration programs in cancer treatment and prevention, and stipulates that NCI devote more resources to prevention, focusing particularly on environmental, dietary and occupational cancer causes.

November 4, —The Health Research Extension Act of provides a two-year extension, which reaffirms the special authorities of NCI and added information dissemination mandates.

A representative from the Department of Energy was added to the National Cancer Advisory Board as an ex officio member. June 10, —The NIH Revitalization Act of encourages NCI to expand and intensify its efforts in breast cancer and other women's cancers and authorized increased appropriations.

Similar language is included for prostate cancer. Department of Defense breast cancer research. PL July 10, —The Radiation Exposure Compensation Amendments of allow more workers who handled radioactive material for weapons programs to be eligible to receive federal compensation for radiation-induced illness.

Postal Service the authority to issue semipostal stamps, which are sold at a premium in order to help provide funding for a particular area of research.

January 4, —The Best Pharmaceuticals for Children Act is designed to improve the safety and efficacy of pharmaceuticals for children, by reauthorizing legislation that encourages pediatric drug research by giving drug companies an incentive of six months of additional market exclusivity to test their products for use in children.

In addition, the CDC is directed to establish and carry out an information and education program. September 10, —The Public Health Security and Bioterrorism Preparedness and Response Act contains a provision instructing Federal agencies to stockpile and distribute potassium iodide KI to protect the public from thyroid cancer in the event of a radiation emergency. June 30, —The Patient Navigator Outreach and Chronic Disease Prevention Act of amends the Public Health Service Act to authorize a demonstration grant program to provide patient navigator services to reduce barriers and improve health care outcomes.

The bill directs the HHS Secretary to require each recipient of a grant under this section to use the grant to recruit, assign, train, and employ patient navigators who have direct knowledge of the communities they serve to facilitate the care of individuals who have cancer or other chronic diseases.

The bill also directs the HHS Secretary to coordinate with, and ensure the participation of, the Indian Health Service, NCI, the Office of Rural Health Policy, and such other offices and agencies as deemed appropriate by the Secretary, regarding the design and evaluation of the demonstration programs. Postal Service's authority to issue special postage stamps to help provide funding for breast cancer research through December 31, January 12, —The Gynecologic Cancer Education and Awareness Act of , or "Johanna's Law" directs the HHS Secretary to carry out a national campaign to increase the awareness and knowledge of health care providers and women with respect to gynecologic cancers.

April 20, —The National Breast and Cervical Cancer Early Detection Program Reauthorization Act of allows states to apply for federal waivers to spend a greater share of funds on hard-to-reach underserved women. Requires NIH to expand the clinical trial registry clinicaltrials. Postal Service to issue a special postage stamp which contributes to funding breast cancer research. Introduction to Grants Process. NCI Grant Policies. Legal Requirements. Step 3: Peer Review and Funding Outcomes.

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