Actively Recruiting
Pasireotide as Maintenance Treatment in Synovial Sarcoma and Desmoplastic Small Round Cell Tumor
Led by University Hospital Heidelberg · Updated on 2025-01-13
28
Participants Needed
4
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
PAMSARC is a non-commercial interventional Phase 2 clinical trial of academic research institutions, with its primary goal being to improve medical treatment of fusion driven Desmoplastic small round cell tumor (DSRCT) and Synovial sarcoma (SySa) in young adults and adolsecents with male predominance. Current management of DSRCT and SySa includes chemotherapy, radiation and aggressive cytoreductive surgery. Despite advances in multimodal therapy, outcomes remain poor with frequent disease recurrence and very limited options for patients with advanced disease. Selected somatostatin receptor (SSTR) family members, i.e., SSTR2, SSTR3 and SSTR5, are frequently overexpressed in DSRCT and SySa, providing the rationale for treatment with somatostatin analogues (SSA). Pasireotide is a SSA with high affinity for SSTR1, -2, -3, and -5 and is approved for the treatment of Cushing's disease and acromegaly and has also shown activity in other cancers. In patients with advanced stage DSRCT and SySa, conventional chemotherapeutic approaches frequently lead to disease response, however, the duration of progression-free time after chemotherapy is short. The targeted approach with pasireotide after initial intensive multimodal treatment may have the potential to significantly improve outcome.
CONDITIONS
Official Title
Pasireotide as Maintenance Treatment in Synovial Sarcoma and Desmoplastic Small Round Cell Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed pathological diagnosis of DSRCT at any stage or Synovial Sarcoma (IRS III, metastatic, or relapsed)
- High SSTR2/3/5 mRNA expression determined by RNA sequencing
- Stable disease, partial or complete response after standard treatment
- Age between 13 and 50 years
- Karnofsky-Index 3 80% for patients 16 years or older; Lansky-Index 3 80% for patients under 16
- No curative treatment option available
- Body weight 3 30 kg and body surface area 3 1.1 m6
- Enrollment within 8 weeks after last chemotherapy (minimum 2 cycles)
- Ability to understand the trial and its consequences
- Written informed consent obtained (for patients under 18, consent from adolescents and parents)
- For women of childbearing potential: negative urine pregnancy test at screening and use of highly effective contraception
- Male patients and female patients with partners of childbearing potential must use two forms of contraception during the study and for 3 months after
- Adequate bone marrow, renal, and liver function by laboratory tests within 14 days before treatment
You will not qualify if you...
- History of hypersensitivity to pasireotide or similar drugs
- Participation in other interventional clinical trials within 30 days
- Uncontrolled diseases, especially diabetes mellitus
- Bleeding disorders
- Therapeutic anticoagulation that cannot be temporarily paused
- Use of prohibited medications
- Resting heart rate below 60/min
- Fasting glucose level above 110 mg/dl
- Severe neurological or psychiatric disorders
- Pregnancy or breastfeeding
- Prior treatment with somatostatin analogues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
National Center for Tumour Diseases, University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
2
Klinikum Stuttgart- Olga Hospital Zentrum für Kinder-, Jugend und Frauenmedizin
Stuttgart, Baden-Wurttemberg, Germany, 70174
Not Yet Recruiting
3
Klinikum Stuttgart Studienzentrale Stuttgart Cancer Center, Tumorzentrum Eva-Mayr-Stihl
Stuttgart, Baden-Wurttemberg, Germany, 70175
Not Yet Recruiting
4
Universitätsklinikum Essen Pädiatrische Hämatologie und Onkologie
Essen, North Rhine-Westphalia, Germany, 45147
Not Yet Recruiting
Research Team
R
Richard F. Schlenk, Professor
CONTACT
E
Editha Gnutzmann, M.A.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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