RecruitingPHASE2INTERVENTIONAL

Pasireotide as Maintenance Treatment in Synovial Sarcoma and Desmoplastic Small Round Cell Tumor

This study, called PAMSARC, is investigating if a drug named Pasireotide (also known as Signifor) can help young people and adults with two rare cancers, Desmoplastic Small Round Cell Tumor (DSRCT) and Synovial Sarcoma. These cancers currently have limited treatment options, especially when they return or are advanced. Researchers believe Pasireotide might work by targeting specific features in these cancer cells. The study is a Phase 2 trial, meaning it's testing if the treatment is effective and safe. The main goal is to see if Pasireotide can prolong the time without the cancer growing back and potentially improve overall survival after patients have had their initial intensive treatments.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Hospital Heidelberg

Enrolment target

Start

19 Dec 2024

Estimated completion

01 Oct 2028

Desmoplastic Small Round Cell Tumor Synovial Sarcoma

What is this study about?

This study is looking into new ways to treat two uncommon types of cancer: Desmoplastic Small Round Cell Tumor (DSRCT) and Synovial Sarcoma. These cancers are often aggressive, meaning they can grow and spread quickly. Current treatments usually involve strong chemotherapy drugs, radiation, and extensive surgery. While these treatments can help at first, the cancer often comes back, and there aren't many good options for patients whose cancer has progressed.

Researchers have found that cells from both DSRCT and Synovial Sarcoma often have special spots on their surface called 'somatostatin receptors'. These are like tiny docking stations. The medicine being tested, Pasireotide (brand name Signifor), is designed to attach to these receptors. Pasireotide is already approved for other conditions like Cushing's disease and acromegaly, and it has shown some promise in other cancers. The idea is that by targeting these specific receptors, Pasireotide could help control the cancer.

This study is aiming to see if giving Pasireotide after standard intensive treatments for these cancers can help prevent the cancer from returning or growing for a longer time. They also want to see if it can help people live longer. By focusing on these specific features of the cancer cells, the hope is to significantly improve how well patients respond to treatment and their long-term health.

Key takeaways

This study explores a new maintenance treatment (Pasireotide) for rare cancers.
It aims to prevent cancer recurrence after initial intensive treatments.
The treatment targets specific receptors on cancer cells.
This is a Phase 2 study, testing effectiveness and safety.
It focuses on Desmoplastic Small Round Cell Tumor (DSRCT) and Synovial Sarcoma.
The goal is to improve long-term outcomes for patients.

Who may be eligible?

This study is looking for people aged between 13 and 50 years who have either Desmoplastic Small Round Cell Tumor (DSRCT) or Synovial Sarcoma. For Synovial Sarcoma, it must be advanced, spread, or have come back after treatment.

To join, your cancer cells need to show specific markers (SSTR2/3/5 mRNA expression) that Pasireotide is designed to target. You must have completed your usual round of strong treatments (like chemotherapy) and your cancer should be stable, smaller, or have disappeared afterward. You also need to be reasonably fit and able to understand what taking part in the study means.

There are also some other requirements, like having a certain body weight and shape. If you are female and could become pregnant, you'll need to have a negative pregnancy test and agree to use effective birth control during the study.

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.

Are you between 13 and 50 years old?
Have you been diagnosed with Desmoplastic Small Round Cell Tumor or Synovial Sarcoma (advanced/recurrent for Synovial Sarcoma)?
Has your cancer responded to your previous standard treatments (stable, smaller, or gone)?
Are you generally fit and well enough for a clinical study?
If female and able to get pregnant, are you willing to use effective birth control and have a negative pregnancy test?
Do you meet the minimum body weight and size requirements?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive Pasireotide via an injection into your muscle (usually your bottom) every 28 days, which is roughly once a month. The dose will be adjusted based on whether you are an adult or an adolescent and your body size. This treatment will continue for a period of time. Throughout the study, you'll have regular checks, including blood tests and scans, to see how the treatment is working and to monitor your health. The researchers will be looking at how long the cancer stays under control and your overall well-being. The study plans to enrol patients over two years starting in 2024, with each participant followed up for at least six months after their last treatment. The study is expected to finish around 2027.

Potential risks and benefits

Taking part in a clinical trial offers the chance to try a new treatment that might be more effective than current options, especially when standard treatments have limited success for advanced or returning cancer. Pasireotide has shown promise, but like all medicines, it can have side effects. These will be carefully monitored, and you will be informed about potential risks. While the hope is for benefits, there's no guarantee the treatment will work for everyone. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

National Center for Tumour Diseases, University Hospital Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting
Klinikum Stuttgart- Olga Hospital Zentrum für Kinder-, Jugend und Frauenmedizin
Verified postcode
Stuttgart, Germany· Not yet recruiting
Klinikum Stuttgart Studienzentrale Stuttgart Cancer Center, Tumorzentrum Eva-Mayr-Stihl
Verified postcode
Stuttgart, Germany· Not yet recruiting
Universitätsklinikum Essen Pädiatrische Hämatologie und Onkologie
Verified postcode
Essen, Germany· Not yet recruiting

Common questions

What is Desmoplastic Small Round Cell Tumor (DSRCT) or Synovial Sarcoma?

These are both very rare types of cancer that often affect young people. DSRCT usually starts in the tummy area, and Synovial Sarcoma often develops in soft tissues around joints.

What is Pasireotide (Signifor)?

Pasireotide is a medicine that targets specific spots (receptors) often found on these cancer cells. It's already used for other conditions and is being studied here to see if it can help control these cancers.

Why is this study important?

Current treatments for these rare cancers are often very intense, and the cancer can still come back. This study aims to find a new way to keep the cancer from returning, which could improve how long patients live and their quality of life.

Will I have to pay to be in the study?

No, clinical trials usually cover the cost of the study drug and related medical visits and tests. You should check with the study team about any potential out-of-pocket expenses.

What 'phase' is this study?

This is a Phase 2 study. This means researchers are testing if the new treatment is effective and safe. Previous studies (Phase 1) would have already checked for basic safety.

How to find out more

Richard F. Schlenk, Professor

richard.schlenk@nct-heidelberg.de +49 (0)6221 56 6228 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.