Lung cancer patients to benefit from clinical trials at Monash Health Translation Precinct

CTC Manager Ms Cheryl Coleman, Professor Eva Segelov
and oncology patient Ms Marnie Dalton

Monash Health lung cancer patients are set to benefit from the relocation of clinical trials to the state-of-the-art Clinical Trials Centre at the Monash Health Translation Precinct (MHTP) in Clayton.

Lung cancer is the fifth most common cancer in Australia but the leading cause of cancer related deaths.  Monash Health receives over 250 new referrals of lung cancer each year, one of the highest patient loads in Victoria, as our area serves a population equivalent to the size of the Adelaide.

“All lung cancer clinical trials are being moved from the Monash Cancer Centre, Moorabbin to the MHTP Clinical Trials Centre, the ‘home base’ for Monash Health and Monash University clinician-scientists to conduct early, mid and late phase clinical trials,” said Dr Muhammad Alamgeer, medical oncologist and lung trials clinical lead at MHTP.

“Currently there are eight clinical trials are being conducted in various subtypes of lung cancer—of these, two trials are phase 2 and the rest are phase 3.  

A number of other patients with lung cancer are also participating in phase 1 clinical trials, which are already running at MHTP.

Dr Alamgeer said the Monash team of motivated and world-class clinicians and researchers strive to ensure patients have access to the latest and most effective treatments, and that further early and late phase clinical trials are planned to start in the coming months.

 “Participation in clinical trials gives our patients the opportunity to receive novel and cutting-edge treatment options,” said Monash University’s Associate Professor Arun Azad, oncologist and Head of Oncology Clinical Trials at MHTP.

“Every cancer patient at Monash Health who is either newly diagnosed or is requiring a change in their treatment is considered for participation in a clinical trial,” said Associate Professor Azad.

Associate Professor Azad said that due to stringent entry criteria, not all patients are eligible to participate in a clinical trial.

Director of Oncology at Monash Health, Professor Eva Segelov said recent advances in medical research have led to the discovery of novel and more effective treatments, resulting in improvements in overall survival and quality of life for lung cancer patients.

“We are very fortunate to have the Clinical Trials Centre, a purpose-built facility supported by dedicated staff with expertise in clinical trials, ranging from pharmacy to nursing, data management and medical care, to our translational scientists who work alongside us to better understand cancer biology,” said Professor Segelov from the Department of Medicine, School of Clinical Sciences at Monash Health.

“Collaborative initiatives at the MHTP bring together information and leading opinion from clinicians and scientists on cancer treatment, prevention, diagnosis and cure.”

“We have planned to move all cancer clinical trials to the MHTP, optimising translational research opportunities, which will result in better outcomes for our patients,” said Professor Segelov.

First patient overnight stay at MHTP Clinial Trials Centre

Mr Rudy Van Ekeren with
Ms Cheryl Coleman

The Clinical Trials Centre at the Monash Health Translation Precinct (MHTP) welcomed their first overnight patient earlier this month.

Mr Rudy Van Ekeren is the second aggressive B-cell lymphoma patient in Australia—and only third in the world—to receive a novel epigenetic therapy as part of an anti-lymphoma clinical trial.  The study is being led by Monash University researcher and Monash Health haematologist Dr Gareth Gregory.

“I’ve been in hospitals around the world and have never seen facilities like this,” said Rudy.

For the first cycle of his trial, Rudy needed to have ten hours of pre-hydration before starting his treatment.

“We needed him here overnight so we could start his treatment in the morning,” said MHTP Clinical Trials Centre (CTC) Manager Ms Cheryl Coleman.  

“Once Rudy started his treatment, we began our observations and a series of blood tests looking for tumour lysis syndrome to make sure the tumour wasn’t breaking down in a dangerous manner.”

Rudy stayed for a second night in the CTC for further observations.

According to Early Phase Drug Trials Operations Manager Ms Cheryl-Ann Hawkins, the first overnight patient in the CTC marks the beginning of a new service and a new era.

“While there are other healthy volunteer clinical trials units in Australia, our CTC is unique in that it offers services across all diseases and phases in unhealthy patients,” said Ms Hawkins.

Ms Coleman said that one of the biggest advantages of the CTC is the Trial Units no longer have to negotiate for a public hospital bed.

“When following a clinical trial protocol, we may only have 28 days for a screening period, and patients must be treated at Day 0 or Day 1,” said Ms Coleman.

“When you’re competing for a public hospital bed in a busy ward, there can often be a delay of a day or two and there’s a chance of losing the patient to the trial.”

“When patients come to our dedicated Centre we can guarantee they’re looked after according to the protocol requirements. Data is collected and recorded at the required time points.”

Ms Coleman said the CTC is not only more attractive to sponsors by providing timely and accurate data but also allows trial units to participate in new trials they would not have been able to consider previously.

For patient Rudy, he was happy to have all the attention of the night shift staff.

“I couldn’t wish for any better treatment, and I was very happy having my wife stay overnight in the room to support me,” he said.

The unique and dedicated Clinical Trials Centre is an Australian first in the public sector, supporting clinical trials from Phase 1 to Phase 4—from ‘first in human’ to primary health trials.

Monash part of world-first clinical trial for lymphoma patients

Mr Potter with Dr Gareth Gregory in the MHTP
Clinical Trials Centre

A novel therapy for aggressive lymphoma is being tested in a world-first clinical trial at the Monash Health Translation Precinct (MHTP).

In early 2015, researchers at Monash University and Peter MacCallum Cancer Centre showed the novel anti-lymphoma therapy is remarkably effective against one of the most aggressive B-cell lymphomas in animal models.

Mr George Potter is the first aggressive B-cell lymphoma patient in Australia—and only second in the world—to receive the new treatment, a drug called dinaciclib, a type of epigenetic therapy that can alter the way a cancer cell reads its own abnormal DNA.

"Certain B-cell lymphomas depend on a cancer causing gene called ‘Myc',” said lead researcher and Monash Health haematologist Dr Gareth Gregory.

"Patients with aggressive lymphoma usually respond well to initial chemotherapy.  Unfortunately, those that relapse or are resistant to upfront therapy have a poor response to further therapies and ultimately have a poor prognosis."

"In the case of aggressive lymphoma, dinaciclib effectively turns off genes that Myc is activating and then kills the cells, including those resistant to conventional chemotherapy," said Dr Gregory.

Dr Gregory and Head of Haematology Research at the School of Clinical Sciences at Monash Health (SCS) Associate Professor Jake Shortt have worked on this type of lymphoma for more than seven years and have tested numerous novel and conventional therapies.

"In animal models, dinaciclib is the most effective treatment we have seen to date by a long way," said Associate Professor Shortt. 

"We've even seen results in animal models that have led to some cures—this is something we have never seen before."

Mr Potter is receiving his treatment at the newly opened Clinical Trials Centre at MHTP.

“I am thrilled and very grateful to be part of this trial,” said Mr Potter.

Dr Gregory said initial results from the clinical trial will be available after two to three months of treatment, but overall assessment will take approximately two years.

“We are quite hopeful this therapy will prolong life and provide durable remissions,” added Dr Gregory.

Lymphomas are the most common form of haematological or blood cancer in Australia, and the sixth most common form of cancer overall.  The incidence of lymphomas has more than doubled over the past 20 years and is continuing to rise, for no known reason.

MHTP Clinical Trials Centre a unique Australian resource

Clinician researchers at the newly opened MHTP Clinical Trials Centre celebrated International Clinical Trials Day last Friday.

Held on 20 May, the event commemorates the day that James Lind began his trials into the causes of scurvy.  Lind's experiments in 1747 on board the HMS Salisbury were run under very different conditions to today.

The state-of-the-art Clinical Trials Centre (CTC) at the Monash Health Translation Precinct (MHTP) provides a ‘home base’ for Monash Health clinician-scientists to conduct early, mid and late phase clinical trials.  Supported by a dedicated clinical trial pharmacy and pathology centre, the CTC pharmacy and pathology staff understand the specific requirements of trial protocols. 

Clinical Trials Centre team at MHTP

”The CTC provides a resource that is available nowhere else in Australia,” said Clinical Lead for the MHTP Clinical Trial Centre Professor William Sievert.

The Centre includes access to chairs for study subjects requiring timed infusions of investigational new drugs and overnight facilities for participants in detailed pharmacokinetic studies.

“Every detail is watched over by clinical trial nurses who ensure that trial protocols are strictly followed while providing care for their study subjects,” said Professor Sievert, who is also Director, Gastroenterology and Hepatology Unit, Monash Health and a Research Group Head in the Centre for Inflammatory Diseases at Monash University.

Since opening late last year, 416 patients have visited the CTC, participating in 83 different clinical trials from 12 trial units, including haematology, oncology, lung & sleep, gastro/liver, diabetes, infectious diseases, gastro IBD, rheumatology, neurology, stroke, emergency and endocrinology. 

“Our clinical research group is focused on treatment for viral hepatitis, hepatocellular carcinoma in addition to care pathways for patients with end-stage liver disease,”said Professor William Sievert.

“We have taken part in studies that have developed new, non-interferon based therapy for hepatitis C that cures more than 90% of patients who are treated.” 

MHTP clinician-researchers are also starting studies that will look at curing hepatitis B, which currently can be controlled but not cured. 

Head of Haematology Research at SCS and consultant haematologist at Monash Health, Associate Professor Jake Shortt is involved in clinical trials for patients with cancers of the blood and bone marrow such as leukaemia, lymphoma and multiple myeloma.

"We use trials as a means to access promising medications for patients in need where they may not be available through the PBS."

Associate Professor Shortt said that in haematology there are a lot of new and effective high cost drugs that are not necessarily available. 

"These drugs often provide a more effective alternative to conventional treatment, including 'chemo-free' regimens. Our studies seek to improve treatment outcomes in patients while saving the hospital system money at the same time."

Medical Oncologist and Head of Phase 1 Clinical Trials Group Dr Ben Markman runs clinical trials in cancer patients, testing new drugs that are early in development.

"We look at the safety of these compounds and how the body reacts to and handles the drugs," said Dr Markman.

"We provide opportunities for cancer patients where there may be no other options or the existing options are inadequate."

 "The MHTP and CTC provides a state-of-the art facility that allows patients to be treated safely and comfortably on these clinical trials."

A truly translational facility, the CTC tackles all phases of trials.

“We have multiple units utilising the floor; we are just not giving Chemo,” said MHTP Clinical Trials Centre Manager Ms Cheryl Coleman.  “We started out with 5 and currently have 11 with two more starting soon with us.”

The CTC provides a hybrid model of care, with both primary and team nursing utilised. The space is shared, as is the experience and skills of the staff.

“We offer a one stop shop: outpatient consults, treatment areas, a dedicated trials pharmacy and a dedicated trials lab all on the same floor,” said Ms Coleman.  

             

The CTC at MHTP accepts trials from Monash Health, Monash University and the Hudson Institute will soon commence work for commercial businesses wanting to bring their technology to the patients.