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

NCT06669013 | Recruiting Phase 3

• 1 other identifier: 821052021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Data from 40 patients are planned to be included in the study to randomize approximately 10 patients. This study involves patients with advanced/metastatic GD2-positive rhabdomyosarcoma after progression on 1st line of chemotherapy, advanced/metastatic GD2-positive Ewing sarcoma after progression on 1st line of chemotherapy and advanced/metastatic GD2-positive osteosarcoma after progression on 1st line of chemotherapy. All patients will receive therapy until disease progression (a total of 6 courses of immunotherapy). The primary objective of the study is to determine the efficacy and safety of dinutuximab beta with investigator's choice of chemotherapy.

Conditions

Bone Sarcoma; Embryonal Rhabdomyosarcoma; Alveolar Rhabdomyosarcoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS will be assessed from the date of the first induction dose of dinutuximab beta to the date of first documented disease progression or death from any cause.

  6 months

Secondary Outcomes (5)

• Overall survival (OS)

  6 months

• Overall response rate (ORR)

  6 months

• Tumor control rate (TCR)

  6 months

• Duration of response (DR)

  6 months

• Immune-associated adverse events (IAAE)

  6 months

Study Arms (3)

Generalized / metastatic GD2-positive rhabdomyosarcoma

EXPERIMENTAL

Generalized / metastatic GD2-positive rhabdomyosarcoma after progression on 1st line of chemotherapy. Chemotherapy options: • CARBO(CARBOPLATIN) + ETO(ETOPOSIDE), IFO(IFOSFAMIDE) + ETO(ETOPOSIDE), CARBO(CARBOPLATIN) + IFO(IFOSFAMIDE) (rhabdomyosarcoma) \+ 6 consecutive cycles of dinutuximab beta immunotherapy

Drug: dinutuximab beta

Generalized / metastatic GD2-positive Ewing sarcoma

EXPERIMENTAL

Generalized / metastatic GD2-positive Ewing sarcoma after progression on 1st line of chemotherapy. • ICE (IFOSFAMIDE+CARBOPLATIN+ETOPOSIDE), TEM(TEMOZOLOMIDE+IRINOTECAN), VCT(VINCRISTINE+CYCLOPHOSPHAN+TOPOTECAN), TC(CYCLOPHOSPHAN+TOPOTECAN), TT(TEMOZOLOMIDE+TOPOTECAN), GEM/TAX(GEMCITABINE+DOCETAXEL) (Ewing's sarcoma) \+ 6 consecutive cycles of dinutuximab beta immunotherapy

Drug: dinutuximab beta

Generalized / metastatic GD2-positive osteosarcoma

EXPERIMENTAL

Generalized / metastatic GD2-positive osteosarcoma after progression on 1st line of chemotherapy. • ICE(IFOSFAMIDE+CARBOPLATIN+ETOPOSIDE), IE (IFOSFAMIDE+ETOPOSIDE), CARBOPLATIN+ ETOPOSIDE, Аi(DOXORUBICIN+IFOSFAMIDE), IFO(IFOSFAMIDE), GEM/TAX(GEMCITABINE+DOCETAXEL) (osteosarcoma) \+ 6 consecutive cycles of dinutuximab beta immunotherapy

Drug: dinutuximab beta

Interventions

dinutuximab beta DRUG

Chemotherapy + Immunotherapy (dinutuximab beta)

Generalized / metastatic GD2-positive Ewing sarcoma; Generalized / metastatic GD2-positive osteosarcoma; Generalized / metastatic GD2-positive rhabdomyosarcoma

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Signed written informed consent form;
• Age under 18 years of age;
• Histologically confirmed GD2-positive osteogenic sarcoma, Ewing's sarcoma, soft tissue and undifferentiated sarcomas;
• 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;
• 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);
• Sufficient cardiopulmonary reserves of the patient's organism (ECG (ELECTROCARDIOGRAPHY) data within normal limits, ventricular ejection fraction \> 75% of the upper limit of normal;
• 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:
• Life expectancy at the time of initiation of therapy within the framework of the study is not less than 12 months
• 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;

You may not qualify if:

• Withdrawal of consent by the patient or his/her parent/guardian.

Sponsors & Collaborators

• N.N. Petrov National Medical Research Center of Oncology: lead

Study Sites (1)

Kulyova Svetlana

Saint Petersburg, 194362, Russia

RECRUITING

MeSH Terms

Conditions

Bone Neoplasms; Rhabdomyosarcoma, Embryonal; Rhabdomyosarcoma, Alveolar

Interventions

dinutuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Rhabdomyosarcoma; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Sarcoma

Study Officials

• Svetlana Kulyova, MD, Phd

  Head of Children's Oncology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Svetlana Kulyova, MD, Phd

CONTACT

+78124399555; Kulevadoc@yandex.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant Group/Arm 1. Generalized / metastatic GD2-positive rhabdomyosarcoma after progression on 1st line of chemotherapy. 2. Generalized / metastatic GD2-positive Ewing sarcoma after progression on 1st line of chemotherapy. 3. Generalized / metastatic GD2-positive osteosarcoma after progression on 1st line of chemotherapy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients with advanced/metastatic GD2-positive rhabdomyosarcoma after progression on 1st line of chemotherapy, advanced/metastatic GD2-positive Ewing sarcoma after progression on 1st line of chemotherapy and advanced/metastatic GD2-positive osteosarcoma after progression on 1st line of chemotherapy.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: May 20, 2021
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)