Study on Pasireotide for Patients with Synovial Sarcoma and Desmoplastic Small Round Cell Tumor

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What is this study about?

This clinical trial is focused on studying two types of rare cancers: synovial sarcoma and desmoplastic small round cell tumor. These are serious conditions that can occur in various parts of the body and are often difficult to treat. The study will use a medication called pasireotide, which is given as a suspension for injection. This means the medicine is in liquid form and is injected into the muscle.

The purpose of the study is to see if pasireotide can help patients with these cancers live longer without the disease getting worse. Patients will receive the medication through a deep intramuscular injection once a month. The study will compare the effects of pasireotide with a placebo to understand its effectiveness better. The trial will last for a period of time, during which patients will be monitored regularly to check on their health and the progress of their disease.

Participants in the study will include those who have already received standard treatments for their cancer and have shown stable disease or some improvement. The study aims to provide more information on whether pasireotide can be a beneficial maintenance treatment for these specific types of cancer. The ultimate goal is to improve the quality of life and survival rates for patients with synovial sarcoma and desmoplastic small round cell tumor.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, weight, and health status. A diagnosis of synovial sarcoma or desmoplastic small round cell tumor is required.

Participants must agree to use two forms of contraception if they or their partners are of childbearing potential. This is necessary throughout the study and for three months after the last dose.

2 initial assessment

An initial assessment is conducted to ensure stable disease or response after standard treatment. This includes laboratory tests to confirm adequate bone marrow, renal, and liver function.

High expression of specific markers (SSTR2/3/5) is verified through RNA sequencing.

3 treatment administration

The treatment involves a monthly deep intramuscular injection of pasireotide. This medication is used to maintain the current health status and prolong the time without disease progression.

The injection is administered once every month for the duration of the study.

4 monitoring and follow-up

Regular monitoring is conducted to assess the effectiveness of the treatment. This includes imaging tests to check for disease progression.

Progression-free survival is measured from the start of the study until disease progression or death, whichever occurs first.

5 study completion

The study is expected to continue until October 2028. Participants will be monitored throughout this period.

Overall survival is also measured from the start of the study until death from any cause.

Who Can Join the Study?

Must have a confirmed diagnosis of either desmoplastic small round cell tumor (DSRCT) or synovial sarcoma (SySa), which are specific types of cancer.
If you are a female who can have children or a male with a partner who can have children, you must agree to use two forms of birth control. This includes a male condom and one other highly effective method. This should start immediately after agreeing to join the study and continue during the study and for 3 months after the last treatment.
Must have good bone marrow, kidney, and liver function as shown by lab tests done within 14 days before starting the study treatment.
Must have high levels of certain markers called SSTR2/3/5 mRNA, which are checked through a special test called RNA sequencing.
Must have a stable disease or show improvement after finishing standard treatment.
Must be between the ages of 13 and 50 years old.
Must weigh at least 30 kg (about 66 pounds).
If under 16 years old, must have a Lansky-Index of 80% or higher. If 16 years or older, must have a Karnofsky-Index of 80% or higher. These are measures of how well you can perform daily activities.
Must not have any treatment options that can cure the disease.
Must have finished at least 2 cycles of chemotherapy, with the last treatment being less than 8 weeks before joining the study.
If you are a woman who can have children, you must have a negative pregnancy test before starting the study and use highly effective birth control methods during the study.

Who Cannot Join the Study?

Patients who do not have locally advanced or metastatic synovial sarcoma or desmoplastic small round cell tumor cannot participate. These are specific types of cancer.
Patients who do not express SSTR2/3/5 in their tumors cannot participate. These are specific proteins found on some cancer cells.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are not part of the specified clinical trial group cannot participate. The study targets a specific group of patients.
Patients who are not male or female cannot participate. The study includes both genders.
Patients who are not considered part of a vulnerable population cannot participate. The study includes certain vulnerable groups.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country	Status
Klinikum Der Landeshauptstadt Stuttgart gKAöR	Stuttgart	Germany
Uqbpettffnqfyfzhbadkt Euimt Aim	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	15.10.2024

Trial locations

Investigated drugs:

Pasireotide

Pasireotide is a medication used in this clinical trial as a maintenance treatment. It is administered through a monthly deep intramuscular injection. The trial aims to evaluate its effectiveness in prolonging the time patients live without their disease getting worse. This medication is specifically being tested in patients with certain types of tumors, namely synovial sarcoma and desmoplastic small round cell tumor, which express specific receptors known as SSTR2, SSTR3, and SSTR5.

Investigated diseases:

Synovial Sarcoma – Synovial sarcoma is a rare type of cancer that typically occurs near the joints of the arm, neck, or leg. It is characterized by the presence of spindle cells and can be aggressive, often spreading to other parts of the body. The disease may initially present as a painless lump, but as it progresses, it can cause pain or swelling. Synovial sarcoma is known for its potential to recur after treatment and can metastasize to the lungs or other organs. It is most commonly diagnosed in young adults and adolescents. The exact cause of synovial sarcoma is not well understood, but it is associated with a specific genetic mutation.

Desmoplastic Small Round Cell Tumor – Desmoplastic small round cell tumor (DSRCT) is a rare and aggressive cancer that primarily affects the abdomen. It is characterized by small, round cancer cells surrounded by dense fibrous tissue. The disease often presents with non-specific symptoms such as abdominal pain or swelling, making early detection challenging. DSRCT tends to occur in young males and can spread to other parts of the body, including the liver and lungs. The tumor is associated with a specific chromosomal translocation, which is a hallmark of the disease. Due to its aggressive nature, DSRCT requires comprehensive management.

Trial ID:

2024-511935-86-00

Protocol code:

HEROES-AYA I

NCT ID:

NCT06456359

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Pasireotide for Patients with Synovial Sarcoma and Desmoplastic Small Round Cell Tumor

What is this study about?

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