miércoles, 1 de junio de 2016

Pembrolizumab for HIV-Positive Patients with Recurrent or Refractory Cancer - National Cancer Institute

Pembrolizumab for HIV-Positive Patients with Recurrent or Refractory Cancer - National Cancer Institute

National Cancer Institute



National Cancer Institute

Trial of Pembrolizumab for HIV-Positive Patients with Recurrent or Refractory Cancer

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest
Thomas Uldrick, M.D. (left), and Robert Yarchoan, M.D. (right), of NCI's HIV and AIDS Malignancy Branch
Credit: National Cancer Institute

Name of the Trial

Pembrolizumab in Treating Patients with HIV and Relapsed, Refractory, or Disseminated Malignant Neoplasms (NCI-16-C-0066; CITN-12). See theprotocol summary.

Principal Investigator

Dr. Thomas Uldrick, NCI Center for Cancer Research

Why This Trial Is Important  

Antiretroviral therapy has increased the lifespans of people infected with human immunodeficiency virus (HIV). In fact, many HIV-positive individuals are now living as long as those who have not been infected with the virus. Although longer lifespans represent a triumph of medical research, living longer also means that more and more HIV-positive people are developing cancers, including those not associated with HIV infection. Cancer is now the leading cause of morbidity and mortality among people with HIV.
Clinical trials of new cancer treatments often exclude people with HIV, citing concerns about drug interactions or immunodeficiency. Therefore, how to extend the latest advances in cancer care to HIV-positive patients remains an important area of cancer research. NCI recommends that HIV-positive patients be included in clinical trials, unless there is a specific reason they need to be excluded. Additionally, cancer studies specific to people with HIV remain important and offer opportunities to evaluate the effect of some cancer agents on HIV infection itself.
NCI’s HIV and AIDS Malignancy Branch is collaborating with the Cancer Immunotherapy Trials Network to conduct a phase I clinical trial of pembrolizumab (Keytruda®) in HIV-positive patients with a variety of recurrent or refractory cancers. Pembrolizumab is animmune checkpoint inhibitor that targets a protein on cytotoxic T lymphocytes called PD-1. Cancer cells often express another protein called PD-L1 that binds to PD-1. The interaction of these two molecules causes T-cell inactivation in the tumor microenvironment, thereby allowing the cancer cells to escape immune attack. Blocking the interaction of PD-1 and PD-L1 with pembrolizumab leads to increased T-cell activity against cancer cells in the tumor microenvironment.
“Checkpoint inhibition may be a useful way to treat a variety of cancers in people with HIV because increased expression of PD-1 is associated with HIV infection itself,” said Dr. Thomas Uldrick, the trial’s principal investigator. Furthermore, many of the cancers commonly seen in people with HIV, such as lung cancer and Hodgkin lymphoma, can be effectively treated with drugs like pembrolizumab in people without HIV.
“However, evaluation of checkpoint inhibitors has never been studied in people with both HIV and cancer.” The use of checkpoint inhibitors in people with HIV requires specific safety evaluation because they may have a range of immune dysfunction, commonly assessed by CD4-positive T-lymphocyte counts, depending on when they started their antiretroviral therapy.
“Consequently, there could be immune-related side effects that might be specific to this patient population. So it’s important that we evaluate the safety of these drugs in people with HIV across a range of CD4-positive T-cell counts,” Dr. Uldrick explained.
“Our hypothesis is that treatment with pembrolizumab will be safe and well-tolerated in people with HIV using treatment strategies that are used in the general population,” he said.
In this trial, HIV-positive patients receiving combination antiretroviral therapy who have cancer that has recurred after or has not responded to previous treatment will receive intravenous pembrolizumab every 3 weeks until either their disease progresses or they experience unacceptable side effects. Treatment may continue for up to 2 years.
Participating patients will be grouped into three cohorts based on their degree of immune dysfunction. Immune dysfunction will be determined by CD4-positive T-cell counts, with patients being classified as having moderate (100-199 CD4+ T cells/microliter [mcL] blood) or mild (200-350 CD4+ T cells/mcL blood) immune dysfunction or relatively normal (greater than 350 CD4+ T cells/mcL blood) immune function. Doctors will monitor the safety and try to determine the efficacy of pembrolizumab treatment in patients taking part in the study.
In addition to cancer endpoints, the researchers will also look at HIV-specific endpoints. “We are working with other HIV researchers to conduct correlative studies looking at questions related to the reservoir of latent HIV in the body and improving immune system function against HIV with the use of pembrolizumab,” Dr. Uldrick said

For More Information

See the lists of eligibility criteria and trial contact information, or call the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The toll-free call is confidential.
  • Posted: May 19, 2016

Cancer Information Highlights

Cancer Information Highlights

NCI Banner



Cancer Information Highlights

National Cancer Institute

Cancer Information Highlights
From the National Cancer Institute
Updating you about cancer causes, prevention, screening, treatment, coping, and more
 
New from NCI
 
Drs. Yarchoan and Uldrick Clinical Trial for HIV-Positive Cancer Patients


People with HIV are living longer and many are now developing cancers linked with older age. NCI researchers are testing the safety of pembrolizumab in HIV-positive patients with cancer that has come back or not responded to previous treatment. Pembrolizumab is an immune therapy drug.
 
tumor conjugate receptor Moles to Melanoma: Recognizing the ABCDE Features


This website uses a series of photographs to help people see how common moles, dysplastic nevi, and melanomas are different. Each series of images is described with its ABCDE features: asymmetry, border, color, diameter (size), and evolving, or changing over time.
 
Use of PET-CT Scans May Reduce Need for Surgery for Head and Neck Cancer


A recent study compared two groups of patients with advanced head and neck cancer. Patients who were monitored with PET-CT scans had fewer operations but similar overall survival rates compared with patients who had neck dissection surgery.
 
PDQ on tablet Cervical Cancer Treatment



We’ve revised our PDQ summary to include more up-to-date information on risk factors for cervical cancer.
 
Pharmacist looking at vial New Drug for Bladder Cancer



We’ve added a drug summary about atezolizumab. The Food and Drug Administration (FDA) recently approved it to treat urothelial carcinoma, which is a type of bladder cancer.
 
Nivolumab for Hodgkin Lymphoma



We've updated our drug summary on nivolumab. Nivolumab is now approved by the FDA to treat classical Hodgkin lymphoma in certain patients who have had a stem cell transplant.
 
Lenvatinib for Kidney Cancer



Our drug summary on lenvatinib mesylate has been updated to include the recent approval from the FDA. Lenvatinib mesylate is now approved to treat renal cell carcinoma, the most common form of kidney cancer.
 
Cabozantinib for Kidney Cancer



The Cabometyx brand of cabozantinib-s-malate was recently approved by the FDA to treat renal cell carcinoma. We've updated our drug summary on cabozantinib-s-malate to include this recent approval.
 
Also of Interest
 
Survivorship



June 5 is National Cancer Survivors Day. Many survivors say that they felt they had lots of support during their treatment, but once it ended it was hard to make a transition to a new way of life. Learn about survivorship after cancer treatment, how to plan for follow-up care, and the physical, emotional, and family issues you may face after treatment.
 
Prostate Cancer



June is Men’s Health Month. Visit our prostate cancer gateway page to learn about prostate cancer treatment, prevention, genetics, causes, screening, clinical trials, research, and statistics.
 
Long Distance Caregiving



Even if you live far away from a loved one with cancer, it's possible for you to give support and help solve problems and coordinate care. Find information about managing the needs of long distance caregivers.

INVITACIÓN | Mayor iniciativa privada para prevenir y reducir la obesidad infantil (DKVApptívate) Recibidos x

Estimados amigos,

DKV Vida Saludable le invita a la presentación del proyecto integral #DKVApptívate, la iniciativa privada más ambiciosa llevada a cabo en España para prevenir y reducir la obesidad infantil.

El proyecto incluye acciones en colegios, un videojuego de salud y el I Estudio sobre la situación actual de la obesidad y el sobrepeso infantil en España. Su objetivo es conocer la magnitud de esta problemática en nuestro país, además de concienciar y determinar cuáles podrían ser las acciones para combatirla.

Creemos que esta iniciativa será de su interés y nos gustaría poder contar con su presencia y con la de aquellos compañeros que considere.

Apreciamos máxima difusión.

Reciba un cordial saludo.

Presentación de #DKVapptívate


La iniciativa #DKVapptívate es un proyecto integral para prevenir y reducir la obesidad y el sobrepeso infantil en España.
Según la OMS, la obesidad infantil es uno de los problemas de salud pública más graves del siglo XXI.
Por ello, desde el Instituto DKV de la Vida Saludable hemos impulsado #DKVapptívate, un proyecto integral para prevenir y reducir la obesidad infantil que incluye acciones dirigidas a públicos distintos: un videojuego que cuenta con el respaldo de los principales youtubers, I Estudio sobre la situación actual de la obesidad y el sobrepeso infantil en España o la Cátedra DKV de Educación para la Salud en la Universidad de Padres, entre otras.
Le invitamos a la presentación de #DKVapptívate, en la que intervendrán:
  • Dr. Josep Santacreu, consejero delegado de DKV Seguros.
  • Dr. Rafael Casas, autor del I Estudio sobre la situación actual de la obesidad y el sobrepeso infantil en España.
  • José Antonio Marina, filósofo y rector de la Universidad de Padres.

Fecha: lunes, 6 de junio
Hora: 10:30 h.
Lugar: Matadero-Central de diseño

Paseo de la Chopera 14, 28045-Madrid

Se ruega confirmar asistencia.

MercatorNet: Getting teens to obey (the right people)

MercatorNet: Getting teens to obey (the right people)



Getting teens to obey (the right people)

Accepting authority is virtuous, but not all authorities are equal.
Mary Cooney | Jun 1 2016 | comment 1 

As children approach their adolescent years, they sometimes revert to their terrible twos as they exert their independence and question our authority. This becomes an important time to work on the third degree of obedience: full submission of one's judgement, for this is when obedience really becomes virtuous.
In his book, Character Building, David Isaacs describes virtuous obedience as:
accepting as one's own decisions those which come from whoever holds and exercises authority, provided they do not go against justice.
As parents of teenagers, we should not be satisfied with the first degree of obedience, simple external compliance. There is no virtue in doing what one is compelled to do. This type of obedience, where a child does a task because he has no choice, may at times have to suffice, but it is not really desirable in the long run. Too much of this in the teenage years only leads to feelings of resentment and rebellion.
Nor should we be content with the second degree of obedience, internal submission of the will. With this type of obedience, a child obeys because he understands and agrees with the reasons for a request. But what happens if he does not understand or agree? Very often children are incapable of grasping our reasons. They lack the experience and maturity to see the wisdom behind our reasoning. Furthermore, you might reason and argue with a child until you are blue in the face and he may still refuse to see your point. Then he will either disobey or be forced to obey.
And so, with young adolescents, we really want to foster the third degree of obedience, full submission of one's judgment, for this is what will actually lead to peaceful relationships with our children and true freedom.
The third degree: virtuous obedience
Let's look again at David Isaac's definition of the third degree of obedience: accepting as one's own decisions those which come from whoever holds and exercises authority, provided they do not go against justice.
If we read this carefully, we come to realize that with virtuous obedience, one obeys, not because he necessarily agrees with or understands the person making the request, but because he recognizes the authority of the person who is making the request. This person might be an expert in a specific field, such as a doctor or a professor, or he might be given a position of civil authority. In any case, when we freely submit ourselves to a person's authority, it is because we recognize that this person is more knowledgable or experienced than we are in a specific area and that he can make better decisions there.
When they are very young, children intuitively sense the (God-given) authority of their parents. But as they enter adolescence, they become increasingly observant and critical. They begin to question our authority, especially if we have not established it during the early years. So the first step in fostering true and virtuous obedience in our children is to establish and use our authority well.
We should understand and respect the limits of our authority. If, during a baseball game, I yell and scream at my son to run to the next base while the coach orders him to stay put, I would be overstepping the boundaries of my authority, especially since I know next to nothing about baseball. We also should avoid undermining our authority by being unrealistic in our demands, inconsistent with our consequences, by pitting ourselves against our spouse, or by being unavailable when our children need us.
We have to work on our relationships with our children so that our authority will not be burdensome but will have a sweetness to it. We are parents, yes, but we also want to cultivate a friendship with our children so they will be open and trusting with us. The best way to do this is by spending quality time with our children. Once or twice a month my husband takes one of the kids out for a date, sometimes for lunch, or simply for an ice-cream. It is a great opportunity to learn what is really going on in the child's heart and mind, and to build that trust and respect which makes our authority easier to accept.
Questioning authority is necessary
When children are around the age of 12 or 13, they begin to develop their analytic powers and to think critically of everything around them. Naturally, they begin to question the authority of others, ours included. This is not bad in itself, in fact I would even say that we should encourage our children to do so. Here's why.
As children get older, they will need to accept the authority of more and more people other than ourselves: teachers, coaches, doctors, priests, policemen, employers, etc. However, sometimes they wrongly attribute authority to those who abuse or should not hold it in the first place. Persuasive peers with strong personalities can command authority over our children, who, in their immaturity, become their loyal followers.
Manipulative people also have a way of usurping authority and imposing it on others. I saw one of the most disturbing examples of this when I was in graduate school. The area next to the school of music was ridden with homeless street kids, mostly run aways and drug addicts. One day I saw a young girl, no older than thirteen, wearing a spiked metal collar around her neck. Walking ahead of her was an older teen punk who held the chain attached to her collar. How he managed to exert his authority over her in such a grossly demeaning way must be a very sad tale, indeed.
So, in order to protect our children from the trap of obeying those people who use or abuse authority without the right to do so, we need to teach them the proper criteria by which they should assess someone's claim to authority.
First, a person should be given authority only if he has superior knowledge, experience, or wisdom. And his authority should be limited to his area of expertise. We do not give a plumber the authority to write medical prescriptions. And while a movie star may have an authority on how someone should produce a movie, she does not have authority in the area of faith and morals.
Second, the person in power should use his authority for the good of others. When a person uses his authority for his own benefit, he abuses his authority. A coach who plays to win regardless of the well-being of his players will quickly lose credibility and trust.
Third, our teenagers need to realize that true authority comes hand in hand with service. A person's readiness to serve is the litmus test for the authenticity of his authority. Our teenagers need to watch for this as they make the decision whether or not to accept a person's claim to authority. Prudence and good judgment are important virtues at this age.
‘Why can’t I make my own decisions?’
A teenager may ask, "Why must I accept other people's authority? What if I want to be free to make decisions on my own?" These are two valid questions. I suggest you have a conversation about them, not during a time of confrontation, but at a time when you and your teen are enjoying each other's company, and he/she is open and receptive.
Of course teenagers want to be free to make their own decisions. But any reasonable teenager should be willing to admit that he is not God. Teenagers are not all-knowing.  So, if one wants to make a good decision, he will need to take the advice of someone who knows better than he does. I'll have to admit, though, teenagers are not always reasonable. It takes a lot of humility and maturity to accept someone else's authority and advice, especially if what is being advised is difficult or unpleasant. This is why the third degree of obedience is so virtuous.
It would be helpful to let our teens know that following good advice is not just for the young. Even the President of the United States has his advisors because there is no way for him to know everything about everything. In fact, a mark of a great leader is his ability to recognize and follow great advice. Yes, a young adult should be free to make his own decisions. But if he wants to make wise decisions, he should accept the advice of those who hold authentic authority.
Freedom as self-mastery
Since teenagers are often hankering for freedom and independence, they need to understand what true freedom is. Contrary to popular belief, freedom is not the ability to do what you want to do, how you want to do it, whenever you want to. Such a thing does not exist (except in the minds of three-year olds, who subsequently take tantrum after tantrum).  One who believes that he should be able to do what he wants, when and how he wants to, is both selfish and immature. For all of our actions effect others, whether we know it or not. Such self-centered inconsiderateness always ends up encroaching on someone else's freedom or well-being. Furthermore, the more we insist on having things go our own way, the more we will be enslaved by our pride and selfishness.
In order to have this right, a person needs to know what he ought to do and have the ability to do it. But knowing what one ought to do takes prudence, good judgement, and the humility to accept as one's own decisions those which come from whoever holds and exercises authority. Sound familiar? It takes obedience! 
Knowing what one ought to do, a person then needs the ability to do it. Many smokers know that they ought to quit smoking, and yet they don't seem to have the ability to do so. Having the ability to do what one ought often requires self-mastery and fortitude. It requires the strength of will to do what one knows is right even if his body and emotions are vehemently protesting. The more a person practices obedience, the more he grows in self-mastery, and the greater his capacity for freedom.
This is how we should show our teens that true obedience leads to true freedom. And true freedom, because it is having the right to do what we ought, enables us to do the will of God, which ultimately leads to true happiness. This is why I tell my kids, "If you want to be happy, learn to obey."
To summarize, if we want our teens to obey with a virtuous obedience, we need to do the following:
* Don't settle for simple external compliance. Foster virtuous obedience, where one obeys, not because he necessarily agrees with the person making the request, but because he recognizes the authority of the person who is making the request.
Establish and use your authority well. Understand and respect the limits of your authority.
* Cultivate a friendship with your children so they will be open and trusting. You want your children to obey out of love, not fear.
* Teach your teens the proper criteria by which they should assess someone's claim to authority: 1) A person should be given authority only if he has superior knowledge, experience, or wisdom. 2) The person in power should use his authority for the good of others. 3) A person's readiness to serve is the litmus test for the authenticity of his authority.
* Show your children that if one wants to make a good decision, he will necessarily need to take the advice of someone who know better than he does.
* Have your teens memorize this: freedom consists not in doing what we like, but in having the right to do what we ought.
* Prove to your teens that true obedience leads to true freedom, which in turn leads to true happiness.
Mary Cooney is a homeschooling mother and former pianist living in Maryland. This article is an edited version of one appearing on her blog.
Read the previous article in this series of two: How to get your kids to obey
- See more at: http://www.mercatornet.com/family_edge/view/getting-teens-to-obey-the-right-people/18147#sthash.kxbfkLwh.dpuf



MercatorNet

Apart from Australian Prime Minister Kevin Rudd in 2008, Barack Obama is the only world leader to have visited Hiroshima, the first city to have experienced the devastation of an atomic bomb. Obviously the topics of World War II and the Bomb were far too sensitive for most Westen politicians to confront. 
Yet Obama's speech there was a rhetorical triumph. He managed to speak eloquently about the most controversial decision ever made by an American president without uttering a word of apology or even of self-defence. How did he do it? Read below....


Michael Cook 

Editor 

MERCATORNET



Obama’s speech at Hiroshima was an oratorial gem

Michael Cook | FEATURES | 1 June 2016
... in which he said nothing and gave nothing away

Read more...
Getting teens to obey (the right people)

Mary Cooney | FAMILY EDGE | 1 June 2016
Accepting authority is virtuous, but not all authorities are equal.

Read more...
Will emerging markets cope with the challenges of an ageing population?

Marcus Roberts | DEMOGRAPHY IS DESTINY | 1 June 2016
Investors are concerned that they won't.

Read more...
‘Peter Rabbit’ vs. ‘Polar Bear’s Underwear: the revenge of the classics

Julia Dent | READING MATTERS | 1 June 2016
A long-lost manuscript is already a bestseller.

Read more...
MERCATORNET | New Media Foundation 

Suite 12A, Level 2, 5 George Street, North Strathfied NSW 2137, Australia 



Designed by elleston

New Media Foundation | Suite 12A, Level 2, 5 George St | North Strathfield NSW 2137 | AUSTRALIA | +61 2 8005 8605 

MercatorNet: Getting teens to obey (the right people)

Las vacunas contra el sarampión, paperas y rubéola: Lo que usted necesita saber - HealthyChildren.org

Las vacunas contra el sarampión, paperas y rubéola: Lo que usted necesita saber - HealthyChildren.org



Viruela - Actualización

Novedades en la página de Viruela de MedlinePlus
05/26/2016 12:03 PM EDT
HealthyChildren.org
Fuente: Academia Americana de Pediatría