Medical Oncology & Hematology Clinical Programs

​​​​As the largest program of its kind in Canada, the Division of Medical Oncology and Hematology treats more patients every day than any other cancer centre​ in Canada—and offers some of the most advanced, novel approaches to medical and hematologic oncology worldwide.

Working inter-professionally as part of each patient’s health care team, our medical oncologists and hematologists are organized into cancer Site Groups and provide assessment and treatment planning and delivery for common, rare and complex forms of cancer.

We offer consultations on chemotherapy and other therapeutic approaches based on the role, indications and benefits of drug therapy in specific, individual circumstances and provide people with cancer access to the largest clinical trials program in Canada. ​

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Blood & Marrow Transplant Program

The largest blood and marrow transplant program in Canada, our inter-professional team of medical, nursing and allied health staff work together to integrate patient care, research and education to improve transplant outcomes for people with hematological disorders such as leukemia, lymphoma, myeloma, severe aplastic anemia, germ cell disorders and other plasma cell disorders.

Our Blood and Marrow Transplant Program offers allogeneic and autologous transplant services to patients. Our team of hematologists and medical oncologists, specialized oncology and apheresis nurses, nurse practitioners and other allied health professionals work collaboratively with each patient’s health care team, including consulting with other Princess Margaret services such as pathology, pharmacy and psychosocial supports where necessary.

Our team has dedicated expertise in the coordination of related and unrelated donor-recipient matches using OneMatch with Canadian Blood Services, the US National Marrow Donor Program and the international collaborative World Marrow Donor Program.

Matched donors donate anonymously by traditional bone marrow harvest or by an apheresis collection process that collects peripheral stem cells or hematopoietic progenitor cells (HPC) for transplantation.

Our centre includes an outpatient Apheresis Centre and in-house, outpatient bone marrow harvesting, as well as access to the Phillip S. Orsino Cell Therapy facility, where cells are stored and treated to ensure the removal of any disease.

Our physician-scientists, advanced oncology nurses and laboratory services are at the forefront of innovating techniques in peripheral stem cell/HPC transplants, including prophylaxis and treatment of graft-vs-host disease, stem cell telemedicine for remote physician and nurse practices and advancing patient safety and research.

Chemotherapy & Transfusion Centre

The Systemic Therapy and Transfusion Unit at Princess Margaret is designed with the patient experience at its core and is the largest centre in North America.

The centre offers the most advanced, state-of-the-art treatment options in a setting that considers the patient experience while also meeting the highest standards for treatment delivery and patient safety, security and privacy.

The 26,000 square foot outpatient facility is equipped to accommodate patients and their companions and respects privacy, while also providing staff better lines of sight to monitor and communicate with patients.

Our team of physicians, nurses, pharmacists and allied health staff work as an integrated team to ensure seamless and efficient care that considers each patient’s individual circumstances and needs.

The pharmacy area has been carefully designed to ensure the safe preparation of medications and, with an eye to the future, includes an isolation room where technicians will be able to safely prepare treatments such as viruses and other biological agents. The centre has also installed a robotic device, the first in Canada, to prepare chemotherapy IV syringes and bags, providing increased safety and efficiency for both pharmacists and patients.

Built to provide a calm, soothing atmosphere for people receiving chemotherapy and transfusions and other supportive therapy, the centre is equipped with wireless Internet, DVD players and a cafe where patients can warm up their food. The centre has dedicated areas for patient education and counselling.


Learn more about the Chemotherapy & Transfusion Centre »

Drug Development Program

The innovation and leadership of the Drug Development Program’s clinical trials have changed the way certain cancer types are diagnosed and treated.

Located in the heart of Toronto’s Discovery District, the Robert and Maggie Bras and Family New Drug Development Program at Princess Margaret has been providing cancer patients with rapid access to novel cancer agents and innovative clinical trials.

Focusing on Phase I and II cancer clinical trials, our group has been a leader in the evaluation and implementation of novel cancer agents while also providing the highest quality of patient care. Led by internationally recognized clinician-scientists Amit and Lillian Siu, the New Drug Development Program has evaluated the anti- effects of new cancer agents in early-phase clinical trials across numerous disease sites, including gynecologic, gastrointestinal, head and neck, breast and prostate, as well as for leukemia.

Our multidisciplinary, inter-professional team of highly skilled staff presents a unique depth and breadth of clinical trials knowledge and expertise. Physician scientists, researchers, technicians, nurses, pharmacists, statisticians and specialized support and clinical trials coordination staff work collaboratively with each patient or participant’s health care team, placing a strong emphasis on applying translational research to our trials program and research approaches.

These early phase clinical trials help evaluate the safety and preliminary antitumor activity of innovative study drugs and immunotherapies, these trials also have a strong emphasis on pharmacokinetics and correlative pharmacodynamic studies. Some correlative pharmacodynamic studies include:

  • Explore and reveal tumor biology and how this differs or is similar across disease types
  • Determine how anti-cancer agents function
  • Investigate how drug resistance occurs
  • Reveal the molecular or genetic factors that may predict patient response or resistance to anti-cancer agents

The resources available at the Princess Margaret enable the conduct of complex studies. Paired research tumor biopsies can be performed to obtain tissues for correlative pharmacodynamic studies. There are also many state-of-the-art technologies and expertise available in house at the Princess Margaret, such as whole genome and transcriptome sequencing, single cell sequencing, circulating tumor DNA analysis, , and tumor xenograft studies from fresh tumor biopsies.

We are also the only adult cancer outside of the United States to have a UM1 grant award from the National Cancer Institute (NCI)for Early Phase Therapeutic Studies. This relationship allows for us to work collaboratively with other academic institutions and investigators in the conduct of early phase clinical trials of NCI’s experimental therapeutic agents in high priority areas of unmet medical needs. The success of this relationship also provides an opportunity for our own investigators to design early phase clinical trials in a collaborative manner.

Lastly, having fostered strong relationships and alliances with industry pharmaceutical companies, the Drug Development Program has a multitude of active early phase clinical trials, expanding the opportunities to provide patients access to novel drug therapies for their specific cancers.

Find out more about our research and open Phase I and Phase II clinical trials.


Precision Cancer Medicine

Princess Margaret researchers are at the forefront of developing personalized cancer medicine and are currently enrolling patients in clinical trials that use new molecular profiling technology to develop treatment plans based on the genetic characteristics of individual tumours.

As new targeted drug therapies become available, the challenge is to understand why a drug works well for one person with cancer but has limited effect for another. By examining the molecular profile that is specific to each patient, our researchers hope to better understand how each individual cancer works and to tailor treatments accordingly.

As leaders in many areas that are building blocks for personalized medicine, including pathology, clinical trials and stem cell research, our researchers are pioneering treatment approaches that are as individual as people with cancer are.

Molecular Profiling Initiatives

In 2012 we implemented an institution-wide initiative, the Integrated Molecular Profiling in Advanced Cancers Trial (IMPACT). The project aimed to provide molecular profiling data to physicians treating people with selected advanced solid tumours. By the end of the project, 2,588 advanced cancer patients were successfully profiled, and a manuscript demonstrating the feasibility and clinical impact of molecularly profiling patients' cancer tumours in a clinical setting was published (Stockley, Bedard et al Genome Medicine 2016).

Building on the success of IMPACT, we developed and launched a new province-wide alliance known as the Ontario-wide Cancer Targeted Nucleic Acid Evaluation (OCTANE) study. OCTANE provides next generation sequencing (NGS)-based molecular profiling at seven Ontario cancer centres: the Juravinski Cancer Centre, London Health Sciences Centres, The Ottawa Hospital, Kingston Health Sciences Centre, Sunnybrook Health Sciences Centre, Mount Sinai Hospital, and the Princess Margaret Cancer Centre. By understanding specific mutations in a given patient's cancer, our doctors will be better equipped to predict tumour behavior, and optimally select individualized therapies for each patient. OCTANE is funded by the Ontario Institute for Cancer Research with support from the Princess Margaret Cancer Foundation.

Liquid Biopsy Program

We also spearheaded an institution-wide initiative to collect and store liquid biopsies for future research under the Liquid Biopsy Evaluation and Repository Development at Princess Margaret (LIBERATE) project. Liquid biopsies are a highly valuable tool as a non-invasive test that can be used to study a patient's cancer. LIBERATE collects liquid biopsies from a variety of patients, including patients at high risk of developing cancer and patients with advanced solid and liquid tumours for testing. Research in this field can lead to development of tests which detect cancer sooner, or to determine why some cancers respond to or resist treatment. This initiative also provides infrastructure for sample collection, processing and storage for many young investigators with interesting concepts involving liquid biopsy. By establishing annotated cohorts of patients with unique clinical scenarios, these young investigators have been able to apply for peer-reviewed grant support to enable them to sequence and analyze their liquid biopsy samples.

The foundational work we have built through LIBERATE is enabling our next phase of work on early-stage cancer interception called NIP IT!, the Non-Invasive Intelligence-based Platform Monitoring Program. NIP IT! is an umbrella platform whereby early-stage cancer patients can have non-invasive samples (blood, stool, radiological images) collected and analyzed to test for molecular residual disease (MRD). Data generated from this platform is combined with other large datasets to better train our AI and machine-learning algorithms. The hope is to develop computational algorithms that will help identify, early on, which patients have cancers that are most likely to relapse based on the various non-invasive tests collected and analyzed after standard treatment. If a patient is found likely to relapse based on these tests, they will be offered enrollment into a clinical trial where they may be able to receive promising new drugs to see if intervening early can improve patient outcomes and increase cancer cure rates. To start, the NIP-IT! platform will focus on early-stage patients with breast, head and neck, melanoma, and gastrointestinal neuroendocrine cancers, as these disease sites have matching interception clinical trials into which patients may enroll if MRD is detected.

CAPTUR

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (NCT03297606) is a nationwide, multi-centre, open-label, basket trial sponsored by the Canadian Cancer Trials Group (CCTG) as its first study in the Precision Medicine portfolio (PM.1). CAPTUR aims to link patients who have undergone molecular profiling across Canada to a variety of commercially available anticancer drugs, supplied by participating pharmaceutical partners. The study co-chairs are Dr. Lillian Siu (Princess Margaret) and Dr. Daniel Renouf (British Columbia Cancer Agency). CAPTUR opened to enrollment in February 2018 and trial performance has been particularly strong at the Princess Margaret site. In May 2019, the Princess Margaret CAPTUR team received the CCTG 2019 Phase III Program Team Award for outstanding trial participation, based on accrual metrics, local activation timelines and compliance metrics.


Tumour Immunotherapy Program

The Tumour Immunotherapy Program (TIP) at the Princess Margaret Cancer Centre is directed by Dr. Pamela Ohashi, a world renowned basic and translational immunologist. The clinical leadership of TIP is shared by Dr. Marcus Butler who leads the immune monitoring laboratory, and Dr. Lillian Siu who integrates TIP with the two other key programs at Princess Margaret, Drug Development Program and Cancer Genomics Program. Together, the three programs form a triad of synergy that supports the institution's core vision to deliver precision cancer medicine. The mission of TIP is to conduct cutting-edge research with expertise spanning from basic immunology discoveries through clinical trials of immune therapies with a focus on improving knowledge of the immune system to better diagnose, detect and target cancers.

The program encompasses both investigator-initiated trials (IITs) and industry sponsored trials. The TIP team develop their protocols based on feedback from discovery and translational research from labs within Princess Margaret; a subset of these studies are supported by an in-house Cell Manufacturing Team that has the expertise to manufacture cell and gene therapies for early phase clinical trials. TIP’s Immune Profiling Team is involved in processing and analyzing patient samples from TIP IITs, with novel technologies including multiplexed immunohistochemistry and imaging mass cytometry. For biomarker research, TIP integrates in-depth correlative analysis into the development of investigator-initiated, multi-omic, biomarker-driven immune checkpoint blockade-based basket studies. In addition to IITs, TIP conducts many adoptive cell therapy trials in solid tumours that include chimeric antigen receptor T cell (CAR T) and T-cell receptor T cell (TCR T) therapies. These trials are conducted using Princess Margaret’s Foundation for the Accreditation of Cellular Therapy (FACT)-accredited facilities for apheresis, cell processing, handling and administration.

AI and Data Science Centre

In 2017, the TIP leadership recognized a gap in research being undertaken at Princess Margaret Cancer Centre and began internal discussions to strategize how to ensure that we continue to be a key player in the new era of personalized medicine. To fill these gaps, we began a proposal that if successful, will enable the creation of an Artificial Intelligence (AI) and Data Sharing Centre intended to facilitate the development of AI tools in basic and translational cancer research. These tools would be used to develop accurate predictors of therapy response, with the goal of assisting clinicians in their treatment decisions, as well as identifying new therapeutic strategies and ways to modulate the tumour microenvironment to prevent the rise of treatment resistance.

Microbiome Initiative

TIP has initiated a Microbiome Research Program in 2018, a collaborative initiative focused on studying the bacteria growing in the gut and other parts of the body to understand how they affect the immune system and the way the body responds to cancer treatments. The program is led by Drs. Lillian Siu, Benjamin Haibe Kains, Wei Xu and Bryan Coburn.

The following TIP trials and research focused on incorporating the microbiome initiative are then proposed and activated in TIP:

  • ROMA-1: Role of Microbiome as a Biomarker in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (Part 1)
  • ROMA-2: Role of Microbiome as a Biomarker in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (Part 2)
  • MET4-IO: The Feasibility Study of Probiotics to Evaluate Effects on Fecal Microbiome in Patients on Immunotherapy (MET4-IO)
  • TIME: Tumour Immunotherapy and Microbiome Analysis Project
  • INSPECT-IO: Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients

Marathon of Hope Cancer Centres Network (MOHCCN)

MOHCCN is an initiative funded by Health Canada and led by the Terry Fox Research Institute, which brings together cancer centres across Canada to “ to share data, harness new technologies and create unprecedented collaborations” (MOHCCN One-Pager). The long-term goal of MOHCCN is to build a pan-Canadian platform for data sharing among cancer researchers and clinicians that includes comprehensive clinical data, whole genome and transcriptome sequencing (WGTS) data, as well as immunophenotyping by immunohistochemistry for 15,000 cancer cases in the first five years and 100,000 cases within the decade. The Princess Margaret Cancer Consortium (PM2C), led by Dr. Lillian Siu, is one of the founding Network members and serves as a regional hub that is setting the standards for future network members.

INSPIRE was selected as one of the seven PM2C cohorts in the MOHCCN’s first year of operationalization. A total of 31 INSPIRE cases were selected for inclusion in MOHCCN, including pseudo-progressors (Yang et al., 2021), head and neck cancer patients, Merkel cell cancer patients as well as patients who received treatment with PARP inhibitors. Matched WGTS of those 31 patient’s tumour and blood samples was completed and analyzed in the Ontario Institute for Cancer Research (OICR) bioinformatics pipeline. Clinically annotated WGTS data is available on the Pugh Lab instance of cBioportal.ca for approved PM2C study members. Additionally, tumour immunophenotyping by multiplex immunohistochemistry (IHC) for six immune cell markers (CD3, PanCK, CD8, CD20, FOXP3, CD68) has been completed for all 31 cases by the Ohashi Lab 's TIP Immune Profiling Team (TIP-IPT). Scientific collaborations have been initiated between participating PM2C investigators to leverage and combine the MOHCCN-generated WGTS, pathology, multiplex IHC and comprehensive clinical data from INSPIRE and other cohorts. This data will be used to address pressing research questions in immunotherapy, including identification of biomarkers, or other features that may predict response or resistance to various IO drugs and PARP inhibitors.

TIP Cell Manufacturing TeamThe Princess Margaret Cancer Centre is the first Canadian centre performing clinical trials of adoptive cell therapy (ACT) using Tumour-Infiltrating Lymphocytes (TILs) and engineered TCR-T cells. The TIP includes a highly specialized in-house Cell Production Team with the capacity to manufacture various types of cell and gene therapies for early phase clinical trials. In these therapeutic approaches, a patient's own white cells (lymphocytes) are manipulated in the laboratory to enhance their ability to fight cancer, and then infused back to the patient. When the manipulation includes genetic modification, it is called gene therapy. These approaches are examples of truly personalized therapy, since each product is made specifically for an individual patient. The manufacturing team allows for the capacity for “home grown” technologies such as Princess Margaret Scientist Dr Naoto Hirano’s Next Generation CAR-T cell study currently accruing at Princess Margaret.

The manufacture of cell and gene therapy products requires highly specialized expertise not only in manufacturing, but also quality control, quality assurance and regulatory aspects. The TIP Cell Production Team has contributed to knowledge translation activities in all of these areas, with other centres across Canada that are setting up cell and gene therapy manufacturing. These activities included consultations, document sharing, assistance with preparing regulatory submissions and workshop presentations.

Trial Logistics

Since 2017, the TIP program continuously plays a central role in leading various complex cell therapy trials at Princess Margaret Cancer Centre and ensure patients to be treated on a FACT (Foundation for the Accreditation of Cellular Therapy) accredited ward. The Foundation's mission is to improve the quality of cellular therapy through peer-developed, education, and accreditation for the benefit of patients. As such, several of our clinicians have joined working groups whose goal is to ensure that our institution has the expertise to safely administer immune effector cells and uphold a standard across the institution. These groups focus on the management of these patients from a flow, resource, and safety perspective.

It is known that patients receiving immune based therapies offered through our trials may develop Cytokine Release Syndrome (CRS), a group of symptoms which can lead to life threatening adverse events. Because the TIP has been one of the first departments in the hospital to enroll patients onto these trials, part of our initiative has been to develop a CRS Management Guidance Document which details the timing on onset, CRS symptom grading system, event management guidelines, as well as pharmacy contacts for accessing medications necessary for the management of CRS. It is our hope that this document serve as the foundation for a standardized guideline for hospital practice.

The TIP Cell Production Team also aligned their quality assurance program with the Princess Margaret Bone Marrow Transplant-Immune Effector Cell (BMT-IEC) Program that is accredited by FACT. The goal is to ensure adherence to quality standards for the collection, processing and administration of cell therapy products.

Immune Profiling

Our comprehensive Immune Profiling Team was established in 2016. The team works closely with investigators and industry partners to plan (grant-writing, protocol design) and carry out critical laboratory tests for state-of-the-art clinical trials and translational research studies. The work done by the Immune Profiling Team ultimately contributes to our greater understanding of cancer biology and how different immunotherapies can enhance the immune system to fight cancer.

The Immune Profiling Team has expertise in processing patient specimens (biopsies, tumour tissues, and blood) and performing multiple cutting-edge laboratory techniques including : high-dimensional flow cytometry (16+ markers), CyTOF (35+ markers), multiplex immunohistochemistry (6 markers) and cytokine analysis, and cell sorting for single-cell RNA sequencing.

The Immune Profiling Team is currently involved in nearly 50 clinical and translational studies at the Princess Margaret Cancer Centre. These include investigator-initiated immunotherapy trials and translational research collaborations to investigate mechanisms of response and immune resistance across various cancer types. Through the Immune Profiling Team, investigators hope to gain critical insights into the changes in patients' genomic and immune landscapes in order to better inform patient selection and future treatment strategies.

Molecular Targeted Drug Therapy

AAs a world leader in the evaluation and application of targeted drug therapies, Princess Margaret offers opportunities to participate in clinical trials of novel molecularly targeted agents through our active Phase I, II and III clinical trial programs.

Molecularly targeted agents are anti-cancer agents specifically developed to block key molecules involved in cancer growth, spread and survival. Some examples of molecularly targeted drug therapies currently available at Princess Margaret are:

  • Eligible treatment with trastuzumab, a HER2-targeting drug for people presenting with metastatic breast cancer and stomach cancer whose tumours express an HER2 receptor on their cancer cells
  • Eligible treatment with BRAF inhibitors in clinical trials for people with advanced malignant melanoma whose tumours harbor the BRAF genetic mutation
  • Eligible treatment with ramucirumab, an angiogenesis inhibitor for people with advanced stomach or esophagus-stomach cancers

Patients can also receive molecularly targeted agents that have been approved by Health Canada and are funded by Cancer Care Ontario.


https://www.uhn.ca/PrincessMargaret/Health_Professionals/Programs_Departments/Breast/Pages/clinical_programs.aspx

https://www.uhn.ca/PrincessMargaret/Education/Continuing_Education_Programs/Pages/continuing_education_programs.aspx
Last reviewed: 1/30/2018
Last modified: 11/1/2023 10:43 AM
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