Bone SarcomaPhase 3FollowTheDINNCT06669013
Chemo-immunotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas
A Phase 3 study testing dinutuximab beta in people with Bone Sarcoma and Embryonal Rhabdomyosarcoma, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bone Sarcoma, Embryonal Rhabdomyosarcoma, Alveolar Rhabdomyosarcoma
- What is being tested?
- dinutuximab beta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 20 May 2021to Sep 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- Withdrawal of consent by the patient or his/her parent/guardian.
- Exclusion of the patient by the investigator for safety or ethical reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Kulyova Svetlana
Saint Petersburg, 194362
Svetlana Kulyova, MD, PhD, +781243995553301, Kulevadoc@yandex.ru
Svetlana Kulyova, MD, PhD, +79213357588, Kulevadoc@yandex.ru
About this study
Official title: A Randomized, Multicenter, Open-label Phase III Study of Dinutuximab Beta With Investigator's Choice of Chemotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas With High Levels of GD2 Expression and Disease Progression During 1st Line Chemotherapy
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.
Read the detailed description
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.
6 cycles of treatment with dinutuximab beta are provided in combination with 6-8 cycles of chemotherapy during the induction therapy phase. Switching from one chemotherapy regimen to another is not allowed. Dinutuximab beta should be administered as a slow intravenous infusion through a separate catheter using an infusion pump.
All patients will receive therapy until disease progression (a total of 6 courses of immunotherapy).
Treatment response will be assessed by the investigator after 2, 4 cycles of treatment and at the end of the reinduction therapy period (i.e., after 6 cycles of dinutuximab beta treatment and 6 - 8 cycles of polychemotherapy). Treatment response will be assessed by tumor response according to the criteria for response assessment in the treatment of solid tumors (RECIST 1.1).
After discontinuation of therapy, all patients will be followed up for 6 months. All patients should be followed up to assess survival unless consent is withdrawn. Long-term follow-up/survival assessment visits will be performed monthly until death, withdrawal of consent, or study termination, whichever occurs first.
- Being tested
- dinutuximab beta
- Medical subject headings
- Bone Neoplasms, Rhabdomyosarcoma, Embryonal, Rhabdomyosarcoma, Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dinutuximab betaDrug
Chemotherapy + Immunotherapy (dinutuximab beta)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: dinutuximab beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Overall survival (OS)
OS will be assessed from the date of administration of the first induction dose of dinutuximab beta to the date of death.
Measured: 6 months
Overall response rate (ORR)
ORR will be assessed by tumor response CR or PR.
Measured: 6 months
Tumor control rate (TCR)
TCR will be assessed by tumor response according CR + PR + stabilization.
Measured: 6 months
Duration of response (DR)
DR will be assessed from initial response to disease progression.
Measured: 6 months
Immune-associated adverse events (IAAE)
IAAE will be assessed from the date of administration of the first induction dose of dinutuximab beta to the date of death.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start20 May 2021
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Svetlana Kulyova, MD, Phd, Principal investigator, Head of Children's Oncology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669013
- Sponsor's protocol ID
- 821052021
- Acronym
- FollowTheDIN
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No