refractory/relapse neuroblastoma and other pediatric solid tumors
Conditions
Interventions
Cohort A(GAIA-102 alone):dose escalation study(3+3 design)
Cohort B(GAIA-102 with Dinutuximab+Filgrastim+Teceleukin):dose escalation study(3+3 design)
Cohort C(GAIA-102 with Nivolumab):apply mutatis m
Sponsors
Kawakubo Naonori
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 |
|---|---|
| cohort A, cohort B : Presence or absense of DLT expression cohort C, cohort D : Presence or absense of DLT expression, Presence or absense of Adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Reponse Rate and presence or absence of new lesions Overall Survival rate and progression free survival rate(6, 12, 18, 24M) Best overall response and lesion control rate -cohort A:using RECIST ver1.1 -cohort B and cohort C and cohort D(neuroblastoma):using RECIST ver1.1 and Revised INRC -cohort C and cohort D(other malignant solid tumors):using RECIST ver1.1 Frequency and severerity of adverse events(using CTCAE ver5.0) Frequency and severerity of immune-related adverse events | — |
Contacts
Public ContactReiko Kitamura
I'cros Co., Ltd.
Outcome results
None listed