Pediatric Solid Tumors, Refractory/Relapse Neuroblastoma
Conditions
Brief summary
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
BIOLOGICALBiological
Intravenous injection of GAIA-102 alone
Sponsors
Kyushu University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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. 3. Patients who have medical history for serious side effect , allergy reaction with regards to concomitant drugs. 4. Patients aged from 1years to 24 years at the time of obtaining consent. 5. 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
1. Patients with brain metastases. 2. Patients diagnosed with cancerous meningitis 3. Patients who received allogeneic hematopoietic stem cell transplant. 4. Patients with active autoimmune disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence or absence of Dose Limiting Toxicity(DLT) expression | 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) | 2 year |
Secondary
| Measure | Time frame |
|---|---|
| Objective reponse rate and presence or absence of new lesions | 2 year |
| Overall survival rate and progression free survival rate | 2 year |
| Best overall response and lesion control rate | 2 year |
| Frequency and severity of adverse events | 2 year |
| Frequency and severerity of immune-related adverse events | 2 year |
Countries
Japan
Outcome results
None listed