Pasireotide as Maintenance Treatment With Monthly Intramuscular Injection in SSTR2/3/5-Expressing Synovial Sarcoma and Desmoplastic Small Round Cell Tumor

What this Trial Is About

Researchers are evaluating the use of pasireotide as a maintenance treatment for young adults and adolescents with fusion-driven Desmoplastic Small Round Cell Tumor (DSRCT) and Synovial Sarcoma (SySa), both aggressive and rare cancers. These tumors often express somatostatin receptors, which pasireotide targets. The study is a Phase 2 clinical trial aiming to improve progression-free survival and overall survival after initial intensive treatment, as current therapies often result in frequent disease recurrence and limited options for advanced cases. Pasireotide, a somatostatin analogue with high affinity for several somatostatin receptor subtypes, is administered via deep intramuscular injection every 28 days. Adults receive 60 mg doses, while adolescents receive either 60 mg or 40 mg depending on body surface area. The study includes a recruitment period of 2 years starting in 2024, followed by at least 6 months of follow-up, with estimated completion in 2027. Safety is continuously monitored, and measurable residual disease is assessed before, during, and after treatment. Participants will be monitored regularly with laboratory tests to ensure adequate organ function and to evaluate disease status according to established criteria. The main outcome measured is progression-free survival up to 4 years, defined by imaging-confirmed disease progression or death. The study requires informed consent and adherence to contraception guidelines for patients of childbearing potential. Overall, the trial assesses pasireotide's potential to extend the time patients live without disease worsening after standard treatments.

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