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New treatment option for Desmoplastic Small Round Cell Tumor
Official title Pasireotide as Maintenance Treatment in Synovial Sarcoma and Desmoplastic Small Round Cell Tumor
ClinicalTrials.gov ID: NCT06456359
What this study is testing
What is Signifor?
Signifor is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for desmoplastic small round cell tumor.
Also referred to as ATC-Code: H01CB05.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 50
You may be able to join if
- Patients meeting all of the following criteria are considered for enrolment into the trial:
- Reference pathological proven diagnosis of DSRCT in any stage; or Reference pathological proven diagnosis of SySa, IRS III, metastatic or relapsed...
- High SSTR2/3/5 mRNA expression, as determined by RNA sequencing in the DKFZ/NCT/DKTK MASTER (ClinicalTrials.gov ID: NCT05852522) or INFORM programs.
- Stable disease, partial or complete response after completion of standard treatment
- Age from 13 to 50 years
You likely can't join if
- Patients presenting with any of the following criteria are not included in the trial:
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in...
- Concurrent or previous treatment within 30 days in another treatment clinical trial / Participation in other ongoing clinical trials.
- Uncontrolled concurrent disease, in particular diabetes mellitus
- Bleeding disorder
- Therapeutic anticoagulation which cannot be paused temporarily in order to ensure safe intramuscular injection
See the full eligibility criteria
- Patients meeting all of the following criteria are considered for enrolment into the trial:
- Reference pathological proven diagnosis of DSRCT in any stage; or Reference pathological proven diagnosis of SySa, IRS III, metastatic or relapsed disease
- High SSTR2/3/5 mRNA expression, as determined by RNA sequencing in the DKFZ/NCT/DKTK MASTER (ClinicalTrials.gov ID: NCT05852522) or INFORM programs.
- Stable disease, partial or complete response after completion of standard treatment
- Age from 13 to 50 years
- For patients (≥16 years): Karnofsky-Index ≥ 80% For patients (\<16 years): Lansky-Index ≥ 80%
- No curative treatment option
- Bodyweight ≥ 30kg and BSA ≥ 1.1m²
- Time from last chemotherapy (at least 2 chemotherapy cycles) to enrollment \<8 weeks
- Ability of patient to understand character and individual consequences of the clinical trial
- Written informed consent (for individuals \<18 years of age an ICF for adolescents and their parents is needed)
- For women of childbearing potential negative urine pregnancy test at screening as well as highly effective forms of contraception have to be in place thereafter
- Evidence of childbearing potential is defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile
- Postmenopausal or evidence of non-childbearing status is defined as:
- Amenorrhea for 1 year or more without an alternative medical cause following cessation of exogenous hormonal treatments plus follicle stimulating hormone (FSH) levels in the postmenopausal range in women not using...
- Chemotherapy-induced menopause
- Surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, total hysterectomy or tubal ligation at least 6 weeks before IMP treatment)
- A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy
- Female patients of childbearing potential and male patients with partners of childbearing potential who are sexually active must agree to the use of two forms of contraception in combination (male condom and one highly...
- Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment:
- Hemoglobin ≥ 10 g/dl
- Neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/µl
- Bilirubin ≤ 1.5 x upper limit of normal (ULN)
- ALT and AST ≤ 2.5 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN
- PT-INR/PTT ≤ 1.5 x ULN
- Albumin ≥ 25 g/l
- Creatine kinase ≤ 2.5 x ULN
- Serum creatinine \ 51 ml/min (calculation according to Crockroft-Gault)
- Patients presenting with any of the following criteria are not included in the trial:
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
- Concurrent or previous treatment within 30 days in another treatment clinical trial / Participation in other ongoing clinical trials.
- Uncontrolled concurrent disease, in particular diabetes mellitus
- Bleeding disorder
- Therapeutic anticoagulation which cannot be paused temporarily in order to ensure safe intramuscular injection
- Is taking or requiring any of the prohibited medication listed in Table 5 (6.4.2)
- Heart rate at rest \< 60/min
- fasting glucose level \> 110mg/dl
- Severe neurologic or psychiatric disorder
- Pregnancy/lactation
- Prior treatment with somatostatin analog \-
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Baden-Wurttemberg, Germany
- Stuttgart, Baden-Wurttemberg, Germany
- Essen, North Rhine-Westphalia, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, Baden-Wurttemberg, Germany; Stuttgart, Baden-Wurttemberg, Germany; Essen, North Rhine-Westphalia, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.