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

Launched by N.N. PETROV NATIONAL MEDICAL RESEARCH CENTER OF ONCOLOGY · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on testing a new treatment approach called chemo-immunotherapy for children and teenagers with certain types of advanced bone and soft tissue cancers, specifically GD2-positive rhabdomyosarcoma, Ewing sarcoma, and osteosarcoma. The goal of the study is to find out how effective and safe a medication called dinutuximab beta is when combined with chemotherapy, especially for patients who have not responded to previous treatments. The trial plans to include about 40 patients, with each participant receiving the treatment until their disease progresses, which could be for a total of six therapy courses.

To be eligible for this trial, participants need to be under 18 years old and have a confirmed diagnosis of the specified sarcomas after having already tried one or more rounds of chemotherapy. Additionally, they should generally be in good health, with enough heart and organ function to handle the treatment. Parents or guardians will need to provide written consent for their child to participate. Throughout the study, families can expect close monitoring of their child's health and response to the treatment, and they will be supported by a team of healthcare professionals. This trial is currently recruiting participants who meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• 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.