Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological, Biological, Biological, Biological.
- Who it may be relevant to
- Registry conditions: Refractory/Relapse Neuroblastoma, Pediatric Solid Tumors. Basic parameters: 1 year — 24 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Cohort A(GAIA-102 alone): Confirm the safety of GAIA-102 alone for refractory/relapse neuroblastoma or pediatric solid tumors with lung metastases, and decide recommended dose for Phase II. Cohort B(GAIA-102 with Dinutuximab): Confirm the safety of GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination for refractory/relapse neuroblastoma and decide recommended dose for Phase II. Cohort C(GAIA-102 with Nivolumab):Confirm the safety of GAIA-102(Follow the recommended doses in Cohort A) with Nivolumab. Cohort D(GAIA-102 with Nivolumab, Teceleukin): Confirm the safety of GAIA-102(Follow the recommended doses in Cohort A) with Nivolumab, Teceleukin.
Interventions
- Biological Biological
Intravenous injection of GAIA-102 alone - Biological Biological
Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination - Biological Biological
Intravenous injection of GAIA-102 with nivolumab combination - Biological Biological
Intravenous injection of GAIA-102 with nivolumab, teceleukin combination
Primary outcome measures
- Presence or absence of Dose Limiting Toxicity(DLT) expression [Time frame: At the end of Cycle1 (Cohort A & C & D: Cycle period is 28 days, Cohort B: Cycle period is 56 days)]
- Frequency and severerity of adverse events(Cohort C＆D) [Time frame: 2 year]
Secondary outcome measures (5)
- Objective reponse rate and presence or absence of new lesions [Time frame: 2 year]
- Overall survival rate and progression free survival rate [Time frame: 2 year]
- Best overall response and lesion control rate [Time frame: 2 year]
- Frequency and severity of adverse events [Time frame: 2 year]
- Frequency and severerity of immune-related adverse events [Time frame: 2 year]
Eligibility criteria
Inclusion criteria
- Patients who have been confirmed to have the following malignant tumor by histological examination
- cohort A : neuroblastoma or malignant solid tumor with pulmonary metastases, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family, osteosarcoma, other cartilage sarcoma, nephroblastoma, hepatoblastoma, germ cell neoplasma, other rare solid tumor (except brain tumor and brain metastases) .
- cohort B : neuroblastoma.
- cohort C \& D : neuroblastoma and other malignant solid tumors, rhabdomyosarcoma, Ewing's sarcoma family, hepatoblastoma.
- Undergoing the following treatment.
- cohort A \& B : Patients who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline.
- cohort C \& D : Patients with neuroblastoma who have completed the dinutuximab regimen and still have residual tumor. Patients with rhabdomyosarcoma, Ewing's sarcoma family, hepatoblastoma who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline.
- Patients who have medical history for serious side effect , allergy reaction with regards to concomitant drugs.
- Patients aged from 1years to 24 years at the time of obtaining consent.
- Patients with performance status(PS) over 50 (Lansky Performance Status Score less than 16 years old) or (Karnofsky Performance Status over 16 years old) at the time of obtaining consent.
Exclusion criteria
- Patients with brain metastases.
- Patients diagnosed with cancerous meningitis
- Patients who received allogeneic hematopoietic stem cell transplant.
- Patients with active autoimmune disease.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Kyushu University Hospital — Fukuoka
Identifiers
NCT: NCT05608148 · GAIA-102-PT