Clinical trials Arkiver - Inven2

Childrens cancer

klarsen — Mon, 28 Jan 2019 17:59:58 +0000

There are several playrooms at Rikshospitalet’s Division of Paediatric and Adolescent Medicine, packed with colourful toys. It’s important that the children here can play as they normally would when they are receiving treatment or taking part in a clinical trial. Photo: Elisabeth Kirkeng Andersen.

– Children are not small adults. This is something that has gradually been understood in terms of pharmaceuticals use. In 2007, a bill was put forward in Europe and the USA stipulating that when the industry develops pharmaceuticals for adults, a separate plan for children must also be developed, and trials with children became more common after that, says Heidi Glosli.

Heidi Glosli is a paediatric oncologist, senior consultant and head of the Pediatric Clinical Trial Unit at Oslo University Hospital.

We are seated in one of the offices furthest along a corridor at the Division of Paediatric and Adolescent Medicine at Rikshospitalet. The office is shared by research nurses and the project coordinator in both temporary and permanent positions who work alongside Glosli.

It functions as an operations centre for planning how to conduct the 18 contract research trials with children taking place here and at Ullevål Hospital. In addition to these contract trials, the Pediatric Clinical Trial Unit is also involved in a number of trials initiated by researchers.

Glosli herself has an office in the corridor by the Pediatric Research Institute (PFI), a separate research unit for children. Between them is a treatment room for children who come to take part in the clinical trials. Their dream is to bring all of this together in one location, but space at the Division of Paediatric and Adolescent Medicine is limited.

“After all, we’re in a good location here. It makes it easy for the paediatricians participating in the trials to stop by, consult us, and bring themselves and us up to speed,” says Glosli.

The sum of efforts leads to success

Heidi Glosli has worked at Rikshospitalet with children suffering from cancer since 2003, and she knows her way around the hospital, as she puts it. This means that she functions as a contact point for the global pharmaceutical companies who wish to conduct trials on children here.

“I’ve said from day one that the companies should come to me, and I will find a principal trial researcher, or take on that role myself in the start-up phase, if this leads to us getting the right people to conduct the trial,” says Glosli.

This service-mindedness has been the key to the unit’s success.

“We’ve made tremendous achievements in a short amount of time. In 2013, we only had one trial, in contrast to the 18 open contract trials we have today. The trials have come to us because we’ve delivered what the industry wants when developing new treatments: We’ve got the trials promptly under way, we’ve managed to involve the right patients, and we’ve delivered good quality results,” says Glosli.

The sum of these efforts has meant that the pharmaceutical companies have come to Glosli, and she has not needed to market either herself or the research unit. From a small-scale start-up characterised by go-ahead spirit and scant resources, the Pediatric Clinical Trial Unit is now a well-functioning and professional unit that gives children an opportunity to take part in trials with new treatments long before they are approved.

Glosli is certain that they could not have achieved these results without the goodwill of the hospital management. The management, on their part, gives their full support to Glosli and her colleagues.

Important trials for Oslo University Hospital

Glosli and her colleagues have built up a well-functioning Pediatric Clinical Trial Unit at Oslo University Hospital in a short space of time. ‘We’re very proud of their achievements,’ says Terje Rootwelt.

He is head of the hospital’s Division of Paediatric and Adolescent Medicine, and emphasises the importance of the trials offered by the Pediatric Clinical Trial Unit.

“These trials make the newest forms of treatment available for sick children to test. We take part in further developing the treatments available to children, and we learn a great deal from this. The contract research supported by the industry also helps us to carry out more of our own research-initiated trials at the research unit,” says Rootwelt.

He points out that they now have strong units at both Ullevål and Rikshospitalet, with a major increase in overall activity, which has been clearly requested by the health authorities.

As for the matter of Glosli’s dream of bringing the units together in a single location, Rootwelt cannot promise anything.

“We currently have good areas available for clinical activities at both Ullevål and Rikshospitalet, with affiliated resources in terms of doctors and nurses. Unfortunately, we do not have any plans to extend the unit’s premises at this time. We will have to see how we can best utilise it in close cooperation with the clinical environments,” says Rootwelt.

Delivering the goods in complex trials

The Pediatric Clinical Trial Unit is conducting trials in all stages. This means from the first time a treatment is given to a child to determining that the treatment is safe, through phases where they see whether the new treatment is better than the standard treatment, to follow-up trials to see how the children are doing over time.

“The trials we are conducting on children are related to many illnesses, including haemophilia, thrombosis, various brain diseases including brain tumours, blood cancer, intestinal infections and MS, and we have received a request for a trial on skin diseases,” says Glosli.

The most complex trial Glosli and her colleagues have participated in is CAR-T, which is a form of immunotherapy intended to treat aggressive blood cancer that can afflict children and adults alike.

CAR-T is the world’s first approved gene therapy developed by the global pharmaceutical company Novartis. The treatment was approved in the USA in 2017 and in Europe in 2018.

Before the revolutionary treatment was approved, it was tested at a selection of hospitals across the world. The Pediatric Clinical Trial Unit was specially selected to conduct trials on children in the Nordic countries. They have conducted and are still conducting these in close cooperation with the Department of Paediatric Medicine.

The children who have participated in the trial have been seriously ill with a type of blood cancer called acute lymphoblastic leukaemia (ALL). The trial has required the involvement of ten of Rikshospitalet’s departments, which was made possible by a firm coordination effort by the project coordinator.

“This trial is a good example of our ability to run the most complex trials around because we have developed the infrastructure we need,” says Glosli.

“Novartis has assigned further CAR-T trials to us that will be run on other types of blood cancer that afflict children, including on children whose condition is not life-threatening,” says Glosli.

Inven2 has previously described these trials, see here.

Reaping recognition from the industry and Inven2

Silje T Næss, who has followed up the trials on the part of Novartis Norge, praises the personnel involved in the trials.

“The Norwegian health personnel conducting the trials have done a great job; they have really stood out with their involvement and dedication. They live and breathe for the patients’ best interests,” Næss says.

Siri Kolle is responsible for clinical trials at Inven2 and is also very impressed by Glosli and her colleagues’ work.

“The Pediatric Clinical Trial Unit has established itself as a competent and important trial unit in Norway and the Nordic countries that is a very attractive partner to pharmaceutical firms. This is due to the tireless efforts of Glosli and the rest of the team at the clinical trial unit, as well as the goodwill of the clinic management,” says Kolle, and continues:

“This engagement, together with good infrastructure, service-mindedness and a high level of expertise, means that the research unit delivers very good results in the trials they participate in, with high quality in all parts of the work. The trials conducted at the Pediatric Clinical Trial Unit are an important part of the treatment currently offered to children and contribute to better treatments for children going forward.”

Heidi Glosli. Photo: Elisabeth Kirkeng Andersen

Facts:

The Pediatric Clinical Trial Unit at Oslo University Hospital was established in 2013 and is part of the Division of Paediatric and Adolescent Medicine.

The unit conducts trials on children for a number of illnesses and currently has 18 open trials. The common goal of all of these trials is to develop the best possible treatments for children.

Heidi Glosli is head of the Pediatric Clinical Trial Unit, and Professor Dr.med. Terje Rootwelt is head of the Division of Paediatric and Adolescent Medicine.

More about Heidi Glosli and the clinical trials:

Interview with Heidi Glosli in this podcast about clinical trials 40:33 – 57:16
How pharmaceutical companies experiment on Norwegian patients

More about pharmaceuticals and children, and clinical trials with children:

The post Childrens cancer appeared first on Inven2.

Melanoma cancer

klarsen — Mon, 28 Jan 2019 17:49:40 +0000

Photo: Istock

The biopharmaceutical company Bristol Myers-Squibb (BMS) is behind the trial. The purpose of the clinical trial is to test a combination of two different immunotherapies: Nivolumab, which is a PD-1 immune checkpoint inhibitor, and another antibody that is not yet on the market.

“The trial combines second and third generation immunotherapy for patients for whom the available treatments have not been effective. It’s too early to draw any conclusions about the effect, but we now have several patients who started treatment two years ago and who are still alive and whose cancer is kept under control. Many of them have been in full-time work throughout the trial, while others have experienced a number of side effects which we need to deal with,” says Marta Nyakas.

Nyakas is a senior consultant at the Norwegian Radium Hospital, an oncologist, and is responsible for the clinical trials on melanoma at the clinical trials unit.

Good collaboration with Oslo

The international trial, which started in 2013 and is set to run for several more years, has enrolled 1,500 patients, and 1,100 patients have already received treatment. This is according to Åsa Schääfof BMS, who is Senior Clinical Site Manager for the Nordic trial and based in Sweden.

“Enrolment in this trial has been very good in the Nordic countries, including Norway. We have collaborated with Marta Nyakas for many years and know that she is good at enrolling melanoma patients, and this trial was no exception. This is very much why Oslo is the preferred partner for us in Norway,” says Schääf.

To the question of how Nyakas and colleagues recruit their patients, the senior consultant answers:

“The recruitment comes because of our weekly multidisciplinary team meetings here at the hospital, where we go through all referred patients and check whether any of them are suitable candidates for our ongoing trials. I also distribute an email with information about ongoing trials to all the hospitals in the South-Eastern Norway health region. I attend many meetings with other professionals where colleagues from across the country ask me about trials, and I also receive calls from various local hospitals,” says Nyakas.

Originally, the trial was only intended to include about a dozen Norwegians, but since interest has been so great, Oslo has continued its recruitment and the trial remains open to new patients.

Filling a gap

Nyakas is very pleased with the good recruitment and that so many patients have been able to take part in the trial.

“As I see it, this trial is filling a gap in the treatment offered. Standard treatment has not been effective for the patients in the trial, and they have no other alternative,” says Nyakas.

She finds it exciting to see how research on melanoma in recent years has been driven by immunotherapy, and how these breakthroughs have spread to other forms of cancer, such as lung cancer and kidney cancer.

“Melanoma is a very difficult indication, and we want to find a treatment that can change it from a fatal to a chronic illness,” says Schääf.

Nyakas confirms that several of the patients have lived good lives for two years while on the treatment.

“It will be very exciting to follow these patients. They still have cancer, but it is stable, so they can be considered patients with a chronic illness,” says Nyakas.

Facts:

The clinical trials unit was established in 1995 and is Norway’s leading centre for experimental cancer treatment.

The unit conducts phase I and II clinical trials in cooperation with cancer researchers from Oslo University Hospital and the pharmaceutical industry. We are one of very few centres in the Nordic countries that has expertise and experience in testing new cancer treatments, such as different forms of immunotherapy. The unit accepts patients from all over Norway and collaborates with leading cancer centres in the Nordic countries (Nordic NECT), Europe and the USA.

The post Melanoma cancer appeared first on Inven2.

Bone marrow cancer

klarsen — Mon, 28 Jan 2019 17:37:39 +0000

Photo: Oslo Myelomatosesenter

Bone marrow cancer is a rare form of cancer that is also known as myeloma. It is characteristic of this form of cancer that it usually becomes resistant to treatment after a certain time, so the patients are dependent on continuous access to new forms of treatment. Thanks to Oslo Myeloma Center, Norwegian patients are able to take part in clinical trials with treatments that will not be generally available until eight or ten years from now.

“In the course of 2018, we have started up a number of clinical trials with revolutionary new treatments for this group of patients, including a CAR-T trial,” says cancer researcher and doctor Fredrik Schjesvold. He is also head of Oslo Myeloma Center.

The centre’s vision is for each individual patient diagnosed with bone marrow cancer to be a trial patient, i.e. that he or she will be able to receive the newest treatments under development.

Biggest in the Nordic countries in just a few years

Siri Kolle, who is responsible for clinical trials in Inven2, has been in close dialogue with Schjesvold for the past few years. She is impressed with what he and his colleagues have achieved in a short space of time.

“In just four years, Schjesvold has built up Oslo Myeloma Center into the Nordic countries’ biggest clinical trial centre for this rare form of cancer, which shows that it is possible to get prestigious and important clinical trials to Norway,” says Siri.

She believes there are many good reasons why the centre stands out among the global competition to conduct trials for the most advanced new treatments.

“The most important factors are that the centre provides good data on patients taking part in the trials, they get the trials promptly under way, and they also include many patients in the trials quickly. These are decisive factors to international pharmaceutical companies choosing an institution for their trials,” says Kolle.

She is clear that in an era where the number of clinical trials is on the decline in Norway, at the same time as there are political demands to increase activity in clinical trials, Schjesvold and his colleagues stand out in a very positive way.

“Oslo Myeloma Center contributes to more activity in clinical trials and, along with other communities, thereby puts Norway on the map. This can lead to more pharmaceutical companies wanting their clinical trials to be conducted in Norway, also for illnesses other than myeloma,” says Kolle.

Schjesvold on his part is highly satisfied with the cooperation with Inven2, and feels that it greatly reduces his and the other scientists’ workload.

“Inven2 does a lot of the administrative work and is also good at guiding us in the right direction by implementing procedures and guidelines to ensure professionalism in all parts of the operation,” says Schjesvold.

Communication is the secret

So why has Oslo Myeloma Center succeeded where others struggle? Back in 2014, they could not offer any active trials to patients. Today, the situation is quite the opposite. As many as 200 patients are now participating in groundbreaking trials, which the centre has succeeded in bringing to Norway despite fierce global competition.

“It has been a fun journey. We’ve initiated many measures that, as a whole, have been successful,” says Schjesvold, and continues:

“Firstly, I’ve been able to concentrate my work on the clinical trials, initially part-time, but now in a full-time position. I’ve travelled to conferences and sung the praise of the centre to pharmaceutical company representatives. Not just at one conference, but again and again. And when we have won trials on the basis of these efforts, we have delivered. We’ve worked hard and quickly included many patients. In this way, we’ve had more to boast about at the next conference and so on,” says Schjesvold.

Schjesvold has also used communication actively because it is no longer an easy task to inform either doctors or patients about open trials.

“I started sending out newsletters by mail early on to both trial centres and doctors who treat myeloma patients across Norway. In these, I write about all current and future the trials, and I enclose a list of which hospitals are included,” says Schjesvold.

He is also conscious of using media to gain the attention of both potential trial participants and their doctors. On several occasions, Schjesvold has personally contacted the Norwegian Broadcasting Corporation (NRK), Dagens Medisin and the newspaper Aftenposten and achieved major coverage of the centre and the available clinical trials.

In addition, the patients themselves have chosen to share their moving stories, which often include how they are managing to live well with their illness thanks to new medicines made available through their participation in a clinical trial.

Exciting developments

The hard work has been fruitful, but the plans for the new trials in 2018 show that the centre has perhaps barely got started?

An example is the trial reported on the cover of the Norwegian newspaper VG and with a major story in February 2018. In this story, former head of intelligence Kjell Grandhagen explains that he is the first myeloma patient in the world to test out a brand new combination of three medicines to treat bone marrow cancer.

“It’s great to be able to offer this trial that Grandhagen is participating in. In addition, we are about to embark on our first trial based on our own research. That’s a major step. We are also incredibly proud to have initiated a trial that I know the whole world wants, and that’s a CAR-T trial,” says Schjesvold.

Praise from the industry

MSD is one of the big global corporations that has had major phase III trials at Oslo Myeloma Center. Clinical Research Manager Frode Bjerkely was responsible for these trials in Norway.

“I would like to praise Fredrik for developing a centre for clinical research that is unique in a Norwegian context. Despite some teething problems initially, it is now a well-established and well-functioning centre. We see a unique competitive attitude as regards patient recruitment and a desire to be attractive to the industry. It could be compared to what we in the MSD see in Israel, a country known for entrepreneurship,” says Frode Bjerkely.

“They managed to become the centre in the world with the most patients per centre in both our trials. Our trials were unfortunately stopped in summer 2017 due to patient safety concerns, and the patients had to discontinue treatment. That sort of thing happens in the development of pharmaceuticals, but they also handled that well, and the patients are still being followed up. If we have relevant trials relating to haematologic diseases, we will definitely suggest using the centre again,” says Bjerkely.

Are you a patient, next of kin or doctor who would like to know more about trials taking place at Oslo Myeloma Center? Contact us via the centre’s website.

Facts

Oslo Myeloma Center

Oslo Myeloma Center is part of the Department of Haematology at Rikshospitalet, Oslo University Hospital. The head of the centre is haemetologist and researcher Fredrik Schjesvold. He has built up the centre from three employees in 2014 to 20 employees in 2018.

Oslo Myeloma Center is the biggest clinical centre in the Nordic countries in the field of bone marrow cancer and is the centre that recruits the most patients in the Nordic countries in all trials they participate in.

Myeloma:

Myeloma, or bone marrow cancer, is a rare and serious form of blood cancer. Around 400 Norwegians receive the diagnosis each year, and about 3,000 currently live with the disease. Treatment is characterised by the patients developing resistance to treatment after a certain time, and thereby dependent on continuous access to new forms of treatment.

Overview of clinical trials:

www.helsenorge.no

www.clinicaltrials.gov