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Recruiting nowPhase 3Up to 18 Years

Chemo-immunotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas

Sponsor: N.N. Petrov National Medical Research Center of Oncology · NCT06669013 on ClinicalTrials.gov ↗

Conditions studied

Bone SarcomaEmbryonal RhabdomyosarcomaAlveolar Rhabdomyosarcoma

What it tests

  • dinutuximab betadrug

Where it's running1 site

1 international site
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

Inclusion Criteria:

1. Signed written informed consent form;
2. Age under 18 years of age;
3. Histologically confirmed GD2-positive osteogenic sarcoma, Ewing's sarcoma, soft tissue and undifferentiated sarcomas;
4. Prior to study enrollment, patients must have been treated with one or more lines of adequate chemotherapy and must have relapsed on this therapy or have refractoriness to it;
5. General satisfactory condition of the patient (Lansky scale activity 80-100% (children under 16 years of age), Karnofsky scale 80-100% (children over 16 years of age); ECOG - 0-1);
6. Sufficient cardiopulmonary reserves of the patient's organism (ECG (ELECTROCARDIOGRAPHY) data within normal limits, ventricular ejection fraction \> 75% of the upper limit of normal;
7. Adequate liver function (ALT (ALANINE AMINOTRANSFERASE) ≤ 2.5 \* VGN, AST (ASPARTATE AMINOTRANSFERASE) ≤ 2.5 \* VGN), kidney (creatinine \<1.5 \* VGN), red bone marrow (granulocytes\> 2.0 \* 109/L, platelets\> 150 \* 109/L).

   Six months later, two additional criteria were formulated:
8. Life expectancy at the time of initiation of therapy within the framework of the study is not less than 12 months
9. Oligometastasis disease (presence of 1 to 5 distant metastatic foci) at restaging at the time of the decision to include the patient in the study;

Exclusion Criteria:

1. Withdrawal of consent by the patient or his/her parent/guardian.
2. Exclusion of the patient by the investigator for safety or ethical reasons.

Updated 2024-11-01 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.