Active not recruitingPHASE2INTERVENTIONAL

Vismodegib in Treating Patients With Advanced Chondrosarcomas

This research trial is investigating a new medication called vismodegib for patients diagnosed with advanced chondrosarcoma. Chondrosarcoma is a type of cancer that starts in the cartilage, and in this study, doctors are focusing on cases where the cancer has spread or is difficult to remove with surgery. The main goal is to find out how effective vismodegib is at slowing down or stopping the cancer's growth over a six-month period. Researchers will also be checking to see if the drug helps people live longer and if it's safe to use. Vismodegib is a type of drug that works by targeting specific pathways that help cancer cells grow. By understanding how this drug works and its effects, doctors hope to improve treatment options for people with this challenging form of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

National Cancer Institute (NCI)

Enrolment target

Start

21 Dec 2010

Estimated completion

21 Jul 2026

Clear Cell Chondrosarcoma Dedifferentiated Chondrosarcoma Locally Advanced Chondrosarcoma Mesenchymal Chondrosarcoma Metastatic Chondrosarcoma Primary Central Chondrosarcoma Unresectable Primary Central Chondrosarcoma

Results

Results from this study

Posted November 2019

Results have been published for this study.

Primary outcome

Clinical Benefit Rate (CBR) Based on Centralized Imaging Review as Per RECIST 1.1

CBR was defined as the percentage of participants with complete or partial responses (CR, PR) or stable disease (SD) per RECIST 1.1. CR was defined as disappearance of all non-nodal target lesions. PR was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Analysis of response was performed based on radiological centralized review. A 2-stage optimal Simon's design with 37 participants (first stage: 17 participants) was used. If 3 or less non-progressions (CR + PR + SD) at 6 months were observed during stage 1 (out of 17 participants), the trial would stopped early. Otherwise, 20 additional patients would be accrued for stage 2. If 11 or more non-progressions (out of 37 participants) were observed at the end of recruitment, further investigation of this therapy would be warranted.

Full results on the registry

What is this study about?

This clinical trial is designed to investigate a new treatment called vismodegib for individuals with advanced chondrosarcoma. Chondrosarcoma is a type of cancer that develops in the cartilage, which is the tough, flexible tissue found in many areas of the body, including the bones. When the cancer is described as 'advanced,' it means it has either grown into surrounding tissues, spread to other parts of the body (metastatic), or cannot be surgically removed.

The study aims to understand if vismodegib can help people with different types of chondrosarcoma, such as clear cell, dedifferentiated, mesenchymal, or primary central chondrosarcoma. Often, when chondrosarcoma is advanced, it can be particularly difficult to treat effectively with standard methods. This trial seeks to find out if vismodegib can offer a new way to manage the disease, potentially by stopping the cancer cells from growing and spreading.

Vismodegib is a medication that's part of a group called chemotherapy drugs, but it works in a very specific way. Instead of a general attack on fast-growing cells, it targets particular signals that cancer cells use to grow and multiply. By blocking these signals, the drug aims to stop the cancer from progressing. Researchers will carefully observe how patients respond to this drug, looking at whether tumours shrink, stay the same size, or stop growing, and what impact it has on their overall health and well-being.

Key takeaways

The study tests a drug called vismodegib for advanced chondrosarcoma.
It aims to see if the drug can stop cancer growth and spread.
Participation involves taking daily pills and regular check-ups.
Doctors will monitor your health and measure tumour changes.
It could offer a new treatment option for challenging cases.
You can stop participating at any time if you choose.

Who may be eligible?

To join this study, you would need to have a confirmed diagnosis of chondrosarcoma, a type of bone cancer. This includes specific kinds like clear cell, mesenchymal, or dedifferentiated chondrosarcoma. Your cancer should also be advanced, meaning it has spread or cannot be removed by surgery, and doctors must be able to measure it accurately on scans.

There are also some requirements about your previous treatments. You shouldn't have had more than three courses of chemotherapy for your advanced cancer, and there needs to be a specific amount of time passed since your last chemotherapy, immunotherapy, or radiotherapy treatment, typically a few weeks.

Beyond your cancer diagnosis, doctors will check your general health, including your blood cell counts, liver, and kidney function, to make sure you are well enough to take part. You also need to have a life expectancy of more than three months. If you are a woman who could become pregnant, or a man, you would need to use two forms of contraception during the study and for a certain period afterwards.

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.

Do you have a confirmed diagnosis of advanced chondrosarcoma?
Can your cancer be measured on scans?
Have you had no more than three previous courses of chemotherapy for your advanced cancer?
Are your blood counts and organ functions (like liver and kidneys) within healthy ranges?
Are you willing to use effective contraception if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive vismodegib as a pill, which you will take every day for 28 days. This 28-day cycle will repeat for as long as the treatment is working for you and if you're not experiencing any difficult side effects. During this time, the medical team will regularly check how you're responding to the medication and monitor your health carefully.

The study will also involve blood tests and scans, including CT scans, to measure the size of your tumours and keep track of any changes. These check-ups will help the doctors understand if the drug is being effective and if it's safe for you. After you stop taking the study drug, for whatever reason, you will continue to have follow-up appointments, typically every three months, to monitor your long-term health and any changes in your cancer.

Potential risks and benefits

Participating in this trial could offer potential benefits, such as access to a new treatment that might help slow down or stop the growth of your chondrosarcoma, especially if other treatments haven't been successful. However, like all medications, vismodegib may cause side effects, and these could vary from person to person. The study team will carefully monitor you for any side effects and manage them as best as they can. It's important to remember that joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (6)

Institut Bergonie Cancer Center
Verified postcode
Bordeaux, France
Centre Oscar Lambert
Verified postcode
Lille, France
Centre Leon Berard
Verified postcode
Lyon, France
Hopital De La Timone
Verified postcode
Marseille, France
Institut Curie Paris
Verified postcode
Paris, France
Gustave Roussy
Verified postcode
Villejuif, France

Common questions

What is chondrosarcoma?

Chondrosarcoma is a type of cancer that starts in the cartilage, which is the flexible tissue in your body, often found within bones.

What is vismodegib?

Vismodegib is a medication that works by targeting specific signals that cancer cells use to grow, aiming to stop or slow down cancer progression.

Is vismodegib a type of chemotherapy?

While it's a cancer drug, vismodegib works differently from traditional chemotherapy by targeting specific pathways rather than attacking all fast-growing cells.

How long will I take the study drug?

You will take vismodegib daily in 28-day cycles, continuing as long as the treatment works for you and you tolerate it well.

What happens after the study treatment?

After you stop the study drug, you'll have regular check-ups, usually every three months, to monitor your health.