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Although the immune system of a melanoma patient can recognize that melanoma needs to be eradicated, it is usually unable to do so. Now, in new study findings just announced, ipilimumab was found to increase overall survival in inoperable stage III or stage IV metastatic melanoma patients who had not received prior therapy. The findings will be submitted to the American Society of Clinical Oncology for potential presentation at its annual meeting in June. Side effects of ipilimumab are related primarily to the overactivation of the immune system, resulting in itching, skin rash and diarrhea. Another idiosyncrasy of the treatment is that even in patients who ultimately see benefits, the disease may initially progress before it stabilizes or the tumor shrinks. Although all melanomas arise from what was once a normal melanocyte (pigment cell), not all melanomas are genetically the same.
Mutations in both of these genes are, in part, responsible for the development and progression of melanoma. Powerful new drugs developed?to target these mutations have been?extremely effective in clinical trials?to date. A unique side effect of this drug is the development of small squamous cell carcinoma skin cancers known as keratoacanthomas, which can be cured by simple resection (surgical removal).
Unfortunately, most patients eventually have suffered melanoma recurrences, and future studies will test the drug in combination with other therapies in the quest for longer-lasting benefits.
Among the potential KIT inhibitors, imatinib mesylate has shown great promise [Figure 1] in patients with the mutated gene.
These results suggest that each genetic subtype of melanoma may respond differently to an identical therapy. Optimizing treatment will require a personalized approach based upon understanding and targeting the underlying genetics of each patient and tumor. Researchers are studying ways to improve on the antitumor effects achieved with ipilimumab, PLX4032, imatinib, and other agents. These therapies represent only the tip of the iceberg, as many new drugs are being developed.
Mohs surgery is accepted as the most effective technique for removing the two most common skin cancers. The new University of Minnesota study set out to look at the decision-making processes that lead women to choose preventative mastectomy.
Dr Kristi Funk was one of the main surgeon's who undertook Angelina Jolie's double mastectomy. Double mastectomies are a bigger operation associated with a longer recovery period and potentially more complications.
The views expressed in the contents above are those of our users and do not necessarily reflect the views of MailOnline. As discussed in that article, these researchers constructed genetically engineered transgenic mouse strains that have genetic changes that mimic those found in human cancers. The human clinical trials being “shadowed” by simultaneous studies in mice included Phase 3 trials of several targeted therapies for lung and prostate cancer. The March 2012 Nature report describes research carried out by a large, multi-institution academic consortium, which included Dr.
Because of the intractability of oncogenic KRAS as a target, researchers have been attempting to develop combination therapies for mutant-KRAS tumors (including, for example, colorectal cancers as well as NSCLCs) that address downstream pathways controlled by KRAS. In the co-clinical trial that is the focus of the 29 March 2012 Nature research report and News and Views commentary, researchers developed a genetically-engineered mouse model to study treatment of mutant-KRAS NSCLCs with either the antimitotic chemotherapy drug docetaxel alone, or docetaxel in combination with the MEK kinase inhibitor selumetinib (AZD6244, AstraZeneca).
In humans with mutant-KRAS NSCLC, many tumors with mutations in KRAS have concomitant genetic alterations in other genes that may affect response to therapy.
In the new co-clinical trial, genetically-engineered mice that showed established lung tumors [as determined via magnetic resonance imaging (MRI)] were randomized to receive either docetaxel, selumetinib, or a combination of the two drugs. In human patients in clinical trials or in treatment for their cancers, performing repeated biopsies to monitor treatment is difficult.
The FDG-PET study in this mouse model supports the use of this imaging method as a biomarker to monitor the course of treatment in humans. The co-clinical trial also allowed researchers to design and validate biomarker strategies, specifically the potential use of the less-invasive FDG-PET to predict efficacy and to monitor treatment. The results of the new co-clinical trial strengthens the contention that co-clinical trials in genetically-engineered mice can provide data that can predict the outcome of parallel human clinical trials. As the producers of this blog, and as consultants to the biotechnology and pharmaceutical industry, Haberman Associates would like to hear from you. In this article, the most downloaded article of Q4 2010, Ranjita Misra, Sarbari Acharya and Sanjeeb K. The application of nanotechnology for cancer therapy has received considerable attention in recent years.
At the JCC, most patients will receive their chemotherapy intravenously in the Chemotherapy Suite located on Level 2.
On the day of your treatment, please bring your Health Card, take your regular medications unless you have been told otherwise and wear comfortable clothes. As part of our medication safety protocols, the nurse will compare your name and identification number on your wristband to the chemotherapy order and the drugs at the beginning of every treatment.
Before starting your chemotherapy, you will take your own pills to stop you from being sick.
Intravenous chemotherapy is given in a vein in the arm or in a special kind of intravenous catheter called a PICC or a PORT. Once your treatment is finished you need to pick up your next appointment time at the Reception Desk. I am thrilled to announce that the NCIC Clinical Trials Group (NCIC CTG) has developed and will lead an international clinical trial of a new class of cancer drug aimed at curing lung cancer in patients who have had surgery and chemotherapy for disease confined to the lung. The trial is being conducted internationally, with collaboration from the Intergroupe Francophone de Cancerologie Thoracique (France), the National Cancer Institute (US), Naples (Italy), the Australasian Lung Cancer Trials Group & National Health and Medical Research Council Clinical Trials Centre (Australia), , the Spanish Lung Cancer Group, the Dutch Society for Pulmonology and Tuberculosis (NVALT), the Central and East European Oncology Group, the Korean Cancer Study Group and the National Cancer Centre Singapore. The Faculty of Health Sciences’ vision is to Ask Questions, Seek Answers, Advance Care and Inspire Change.
The following is a guest blog from Angela Luedke, PhD student, Centre for Neuroscience Studies. One of the best things about being a Dean at Queen’s is the close and special relationship I have with our three academic hospitals in Kingston.

Over the past 10 years, our understanding of the biology of melanoma and the body’s natural defensive responses to this disease has increased dramatically. However, in the mid-90’s, the laboratory of James Allison, PhD, Chairman of the Immunology Program at Memorial Sloan-Kettering Cancer Center in New York City, identified the function of an immune-regulating molecule called cytotoxic T lymphocyte-associated anti- gen-4 (CTLA-4). Ipilimumab is a monoclonal antibody, an immune protein that binds to CTLA-4 and inhibits it from functioning.
The study specifically showed that ipilimumab combined with the chemotherapy dacarbazine increased overall survival, while dacarbazine alone did not.
According to the best estimates, ipilimumab may offer many patients a 2-year survival advantage, with a smaller percentage of patients being virtually cured. For this reason, early clinical trials were at first deemed a failure before patients started to improve. A drug called PLX4032 (also?known as Rg7204 or RO5185426), ?developed by Plexxicon in partner-?ship with Roche, targets BRAF?mutations, including the v600E?mutation [Figure 1].
Although three small initial studies of imatinib in patients with advanced melanoma showed no significant anti-tumor effect,8-10 these studies did not require the presence of a KIT mutation in patients.
Based partly on these results, larger trials comparing the efficacy of chemotherapy versus g SK2118436, another BRAF inhibitor, in BRAF-mutant melanoma, as well as chemotherapy versus nilotinib, a newer KIT inhibitor, in KIT-mutant melanoma, are ongoing. It is very possible that using these treatments in combination will produce even more exciting results for melanoma patients. Kim KB, Eton O,Davis DW,et al.Phase II trial of imatinib mesylate in patients with metastatic melanoma. The research found women with early-stage breast cancer in one breast are increasingly opting to undergo a more aggressive operation to remove both breasts.This comes just a week after eminent British surgeon, Professor Kefah Mokbel of the London Breast Institute, warned that would be pointless for women who are not in the same category as Jolie.
Now comes an article on the use of a co-clinical trial strategy in personalized treatment of non-small cell lung cancer (NSCLC) in the 29 March 2012 issue of Nature. These mouse models spontaneous develop cancers that resemble the corresponding human cancers. Xenograft models in which tumor tissue from the patients had been transplanted into immunosuppressed mice were also being tested in parallel with the genetically engineered mouse models.
In the parallel human clinical trial, researchers are also studying treatment of patients with mutant-KRAS NSCLC with docetaxel alone or docetaxel plus selumetinib.
Therefore, the co-clinical trial researchers wished to design mouse models with lung tumors with either Kras mutations alone or with mutations in both Kras and another gene that is often concomitantly mutated in mutant-KRAS NSCLCs in humans. For tumors with only a Kras mutation, treatment with docetaxel alone resulted in a modest rate of response, with 30% of mice showing a partial response. They performed these studies using two different methods–immunostaining of cancer nodules for phosphorylated ERK, and immunoblotting of tumor lysates.
On the basis of their prior studies of signal transduction in mutant-Lkb1 lung tumors, the researchers focused on AKT and SRC. In moribund animals that had received this treatment, all tumor nodules examined showed a recurrence of ERK phosphorylation.
This prediction is consistent with the early results of a Phase 2 clinical trial of these two drug combinations in second-line treatment of patients with KRAS-mutant NSCLC. Since LKB1 status is not being prospectively assessed in the ongoing human clinical trial, the presence of patients with cancers having concurrent LKB1 mutations may diminish the differences between treatment arms based solely on KRAS status.
Co-clinical trials can also be used to generate new hypotheses for use in analyzing concurrent human trials, and for design of future clinical studies. If you are in a biotech or pharmaceutical company, and would like a 15-20-minute, no-obligation telephone discussion of issues raised by this or other blog articles, or of other issues that are important to  your company, please click here. Cancer nanotechnology (an interdisciplinary area of research in science, engineering and medicine) is an upcoming field with extensive applications. Please also remember to bring any medication that you might need during your stay especially your pills to prevent you from being sick and your pain medication.
When it is your turn to have your chemotherapy, the nurse will call you by number rather than your name. Other pills or intravenous drugs may also be given to you to prevent possible side effects. Treatment is different for everyone so your chemotherapy may take only minutes or up to several hours to give.
This research contract with AstraZeneca is the largest in the history of the Faculty of Health Sciences. Lung cancer is the second most common cancer in North America and is the leading cancer killer in both men and women. Its primary mission is to assess the effectiveness of interventions to prevent the development of cancer or improve the care of those patients who do develop cancer What started as a small operation has now grown into a sophisticated organization with 100 staff, a dozen senior investigators, partnerships with centres across the globe and ongoing support from the Canadian Cancer Society.
CTLA-4 inhibits activated immune cells, preventing them from attacking the body’s own tissues. However, in rare cases more dangerous side effects can occur, so patients are urged to enter clinical trials with physicians who are well versed in treating its toxicities. In late March, 2011, ipilimumab became the newest drug to be approved by the FDA for treatment of advanced metastatic melanoma. Drug therapies have been developed to inhibit these mutations, shutting off the cancerous proliferation. Results from?the first clinical trial of this agent?demonstrated major tumor shrink-?age in an unparalleled 81 percent?of patients whose tumor harbored?the BRAF mutation.7 Never before?has a single drug been shown to?induce such a significant response in so many patients. In newer trials that enrolled only patients whose tumors harbored genetically active KIT mutations, 20 to 30 percent of patients treated achieved a major response. His research is focused on the development of novel therapies for advanced melanoma based upon our emerging understanding of the molecular heterogeneity of this disease. Her research interests include melanoma, gastrointestinal oncology and developmental therapeutics.
Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. High-dose recombinant Interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993.
Multicenter phase II trial of high-dose imatinib mesylate in metastatic melanoma: significant toxicity with no clinical efficacy.
A phase II study of imatinib mesylate (IM) for patients with advanced melanoma harboring somatic alterations of KIT.

This project represents the most rigorous test to date of how well genetically engineered mouse models of cancer can predict clinical outcomes. This trial utilized two genetically-engineered PDGF (platelet-derived growth factor)-driven mouse models of the brain tumor glioblastoma multiforme (GBM), one of which had an intact PTEN gene and the other of which was PTEN deficient.
It focuses on strategies for treatment of patients with non-small-cell lung cancer (NSCLC) with activating mutations in KRAS (Kirsten rat sarcoma viral oncogene homolog). Strategies discussed in that report are based on the finding that KRAS controls signal transduction via two key pathways: the B-Raf-MEK-ERK pathway and the PI3K-Akt pathway. The researchers therefore constructed mouse models with cancers bearing the activating Kras(G12D) mutation, either alone or together with an inactivating mutation in either p53 or Lkb1. Mice that bore mutant-Kras tumors that also had mutations in either p53 or Lkb1 had much lower rates of response to docetaxel monotherapy (5% and 0%, respectively), and more of these mice showed progressive disease on MRI or died of their disease. The addition of selumetinib to docetaxel significantly prolonged progression-free survival in these mice. This suggested that acquired resistance could be at least in part due to reactivation of MEK–ERK signaling despite ongoing treatment with selumetinib. The results of the co-clinical trial suggests that researchers perform retrospective analysis of p53 and LKB1 status in samples from the concurrent human clinical trial. Moreover, co-clinical trials can result in the validation of improved animal models for human cancers, which can be used in research and preclinical testing of oncology agents, and in validation of biomarkers for clinical studies in oncology. It provides a unique approach and comprehensive technology against cancer through early diagnosis, prediction, prevention, personalized therapy and medicine.
Our ongoing efforts in the NCIC CTG serve to reinforce our FHS industry engagement strategy, which strives to fortify existing relationships with industry and to promote and develop new ones. The new drug, MEDI4736 (AstraZeneca), is one of a new class of pharmaceuticals that helps the body’s immune system recognize and attack cancer. The trial exists because we asked questions: how can we think about different ways of treating lung cancer?
Indeed, this past year, clinical trials testing several of these new treatments have demonstrated substantial tumor shrinkage, a prolonged remission interval, and even improved overall survival — benefits never achieved before. In a large phase III trial of 676 advanced, inoperable melanoma patients published in 2010 in the New England Journal of Medicine, subjects previously treated unsuccessfully with other agents who received ipilimumab or ipilimumab plus a melanoma vaccine (gp100) lived on average 32 percent longer and had a 20 percent greater chance (45 percent vs. Subsequently, a published phase II study and a recently announced, but as yet unpublished, phase III study have confirmed extended progression-free survival (a longer interval without the disease worsening) as well as significantly extended overall survival compared to patients on dacarbazine, with responses lasting from two to more than 18 months. In this trial, researchers tested the Akt inhibitor perifosine (Keryx Biopharmaceuticals, an alkylphospholipid) and the mTOR inhibitor CCI-779 (temsirolimus; Pfizer’s Torisel), both alone and in combination, in vitro and in vivo.
These mutations occur in 20–30% of NSCLC cases, and patients whose tumors carry KRAS driver mutations have a poor prognosis. The researchers achieved this via a conditional mutation system using nasal instillation of specifically genetically-engineered adenoviruses.
HIF-1? expression in turn upregulates the expression of its downstream effectors hexokinase II and glucose transporter 1 (GLUT1), which are involved in cellular utilization of glucose. Evaluation of resistant tumor nodules suggested that more than one mechanism for pathway reactivation was occurring; study of these mechanisms is ongoing. Future clinical trials should then be designed that involve prospective analysis to ensure sufficient enrollment of patients with all three genotypes to enable sufficiently powered sub-group analyses. Any mechanisms of acquired resistance discovered in co-clinical studies should be confirmed in human clinical trials by examining biopsy samples from patients who relapse on therapy. Target-specific drug therapy and methods for early diagnosis of pathologies are the priority research areas in which nanotechnology would play a vital part. For safety reasons, we ask that you bring only one family member or friend with you into the treatment area.
Drugs in this class have already been approved for use in patients with malignant melanoma, but this will be the first trial in the world to test the drug in the setting of early lung cancer treatment. 25 percent) of surviving one year than those who received gp100 alone.4 And 24 percent were alive after two years, compared with just 14 percent of those treated with the other therapy. The results will likely be presented formally in June at the American Society of Clinical Oncology’s annual meeting.
The goal of this two-year project is to determine to what extent the mouse models are predictive of patient response to therapeutic agents, and of tumor progression and survival. The drugs and drug combinations were tested in cultured primary glioma cell cultures derived from the PTEN-null and PTEN-intact mouse PDGF-driven GBM models, and in the animal models themselves. As discussed in our 2011 report, researchers are attempting to develop treatments of mutant-KRAS tumors that involve combination therapies with an inhibitor of the mitogen-activated protein kinase (MEK) together with an inhibitor of phosphatidylinositol 3-kinase (PI3K).
LKB1-deficient polyps in this mouse model thus show increased expression of hexokinase II and GLUT1, resulting in dramatically increased glucose utilization. The ability to assess mechanisms of resistance in preclinical or co-clinical animal studies may enable researchers to design rational drug combination strategies that can be implemented in future clinical studies.
It was two years of hard work to pull together this trial with our industry partner, Astra Zeneca and to solidify relationships with collaborators across the world. The impact of this trial cannot be overemphasized, as ipilimumab was shown to be the first treatment ever to improve overall survival in advanced melanoma patients. The studies may thus result in validated mouse models that are more predictive of drug efficacy than the currently standard xenograft models.
Researchers are also attempting to develop combination therapies of MEK inhibitors with standard cytotoxic chemotherapies, which if successful will avoid having to use combinations of two expensive targeted therapies. It is from these cells that the NSCLC-like tumors arose, analogous to the clonal origin of sporadic lung tumors in humans. As a result, together we are inspiring change with a resolve to turn the way that we think about cancer on its head: from a disease that always wins, to a disease that we can consistently defeat. The researchers studied MEK-ERK activation (as determined by phospho-ERK staining) in  a set of 57 human NSCLC tumors with known RAS, p53 and LKB1 mutation status. As with the tumors in the mouse model, of seven patients whose tumors harbored the KRAS activating mutation, the three patients with concurrent p53 mutations showed higher levels of ERK activation.

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