Active not recruitingPHASE2INTERVENTIONAL

A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours

This study is investigating two medicines, Sunitinib and Temsirolimus, for people living with advanced rare cancers. Standard treatments don't always work for these cancers, and doctors are looking for better options. The study's main goal is to see if either Sunitinib or Temsirolimus can shrink these particular cancers. They'll start by testing Sunitinib. If it doesn't help, they will then try Temsirolimus. This type of research, called a Phase II study, helps doctors understand how well new medicines work and what side effects they might have. It's an important step in finding more effective treatments for challenging cancers.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Canadian Cancer Trials Group

Enrolment target

137

Start

09 Feb 2012

Estimated completion

30 Jun 2026

Advanced Rare Tumours

What is this study about?

When someone has a rare type of cancer that hasn't responded well to standard treatments, it can be very distressing. Doctors are always looking for new ways to fight these cancers, and that's where studies like this one come in. This particular study is focusing on two specific medicines, Sunitinib and Temsirolimus, to see if they can help shrink advanced rare tumours.

Think of it like this: current treatments for these rare cancers are often limited, and while some might work for a while, doctors need better solutions. This study is an important step in exploring new possibilities. They will first test Sunitinib to see if it has a positive effect. If not, they will then try Temsirolimus. This allows researchers to gather crucial information about how these drugs work against these specific cancer types.

By taking part, individuals contribute to medical knowledge that could ultimately lead to improved treatments for others in the future. It's about finding out more about these medicines and their potential to make a difference.

Key takeaways

This study explores two potential new medicines for specific rare cancers.
It aims to find out if Sunitinib or Temsirolimus can shrink these tumours.
Participation could offer access to treatments not yet widely available.
Eligibility is strict, focusing on advanced rare cancers with limited treatment options.
You will be closely monitored for effectiveness and side effects.

Who may be eligible?

To join this study, your doctor will need to confirm you have one of several specific rare cancers, such as certain types of vascular sarcomas, clear cell carcinomas, medullary thyroid cancer, or a type of neuroendocrine tumour. Also, if you have other rare tumours with certain genetic changes that Sunitinib or Temsirolimus might target, you could be considered. For a specific type of cancer called Ewing's Sarcoma, you'd need to be at least 5 years old, but for most other cancers in the study, you need to be 16 or older.

Your cancer must be advanced, meaning it cannot be safely removed by surgery, or it has spread to other parts of your body. Importantly, there should be no standard, well-proven treatments that are expected to prolong your life. The doctors will also need a sample of your cancer tissue from when you were first diagnosed. They'll also need to be able to measure your tumour on scans or physical exams.

All patients will need to have up-to-date scans (taken within 21 or 28 days before joining) to confirm the cancer's presence and whether it can be measured. Generally, you need to be at least 16 years old to participate, though there's an exception for Ewing's Sarcoma where the age limit is 5 years.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have one of the listed rare cancers (e.g., specific vascular sarcoma, clear cell carcinoma, medullary thyroid cancer).
My cancer is advanced, meaning it cannot be removed by surgery or has spread.
There are no standard, life-prolonging treatments currently available for my cancer.
I have a sample of my cancer tissue available from a previous diagnosis.
I am at least 16 years old (or 5 years old if I have Ewing's Sarcoma).
My cancer can be measured on scans or by a doctor's examination.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first undergo some screening tests to ensure the study medicines are right for you. If you qualify, you would receive either Sunitinib or Temsirolimus. These medicines are given as tablets (Sunitinib) or through a vein (Temsirolimus). You would have regular visits to the hospital or clinic for blood tests, physical examinations, and scans to monitor how the medicine is affecting your cancer and to check for any side effects. The frequency of these visits would vary depending on the stage of the treatment. You would continue treatment for as long as it is helping you and as long as side effects are manageable. The overall duration of your participation would depend on your individual response to the treatment.

Potential risks and benefits

Potential benefits of joining this study could include access to new medicines that are not yet widely available, which might help shrink your cancer or slow its growth, potentially improving your quality of life. However, there's no guarantee the medicine will work for you. As with all medicines, there are potential risks, including side effects that can range from mild to more serious; your care team will monitor you closely for these. You will be fully informed about these risks before deciding to join. Remember, taking part in a study is completely voluntary, and you have the right to withdraw at any time for any reason, without affecting your future medical care.

Locations (17)

Tom Baker Cancer Centre
Verified postcode
Calgary, Canada
Cross Cancer Institute
Verified postcode
Edmonton, Canada
BCCA - Cancer Centre for the Southern Interior
Verified postcode
Kelowna, Canada
BCCA - Vancouver Cancer Centre
Verified postcode
Vancouver, Canada
CancerCare Manitoba
Verified postcode
Winnipeg, Canada
QEII Health Sciences Centre
Verified postcode
Halifax, Canada
Izaak Walton Killam (IWK) Health Centre
Verified postcode
Halifax, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Verified postcode
Hamilton, Canada
London Regional Cancer Program
Verified postcode
London, Canada
Ottawa Hospital Research Institute
Verified postcode
Ottawa, Canada
Hospital for Sick Children
Verified postcode
Toronto, Canada
Univ. Health Network-Princess Margaret Hospital
Verified postcode
Toronto, Canada

Common questions

What is a 'Phase II' study?

Phase II means it's an earlier stage of drug testing. It's designed to see if a new medicine works for a specific condition and to check for side effects, without comparing it to another treatment.

Are these medicines new?

Sunitinib and Temsirolimus are established medicines used for some other cancers, but this study is testing them for specific rare tumours where standard treatments are limited.

Will I know which medicine I'm getting?

Yes, in this study, the doctors will start by giving Sunitinib. If it doesn't help, they will then switch to Temsirolimus, so you will know which medicine you are receiving.

What if the medicine doesn't work for me?

Your doctors will regularly check how you're responding. If the medicine isn't helping your cancer or if you have too many side effects, they will discuss other options with you.

Will this study cure my cancer?

This study is looking for ways to treat and potentially shrink rare cancers for which there is no known cure at the moment. While it might help manage your cancer, it's not expected to be a cure.