Neuroblastoma
Conditions
Interventions
Experimental group:Study drug IR-101 administered with Dose Escalation
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of high-risk neuroblastoma: Patients with a diagnosis of iobenguane (iodine-labeled MIBG) scintigraphy, high-risk neuroblastoma with relapsed or progressive disease according to the revised International Neuroblastoma Response Criteria (Revised INRC) at the time of study enrollment, regardless of the overall response to prior therapy; 2. Criteria for soft tissue lesions: All soft tissue lesions found on CT/MRI scans must be iobenguane scintigraphically positive lesions, or: (1) Any progressive iobenguane scintigraphy-negative lesions found by routine imaging examination, judged by the investigator to be non-neuroblastoma lesions; (2) Any other scintigraphically negative lesions found by routine imaging examinations, which are fibrotic or cicatricial masses, and confirmed by the investigator; 3. Contraceptive Requirements: (1) Male patients: must agree to use contraceptive methods deemed appropriate by the investigator (such as: ligation, condoms) or ensure that the partner uses an effective contraceptive method, and must not donate sperm during the study period and within 90 days after the last dose of the study drug; (2) Female patients of childbearing potential: The serum pregnancy test result must be negative before each study drug administration. If a sexually active patient, an effective method of contraception (such as an intrauterine device, double barrier method, or male partner sterilization) must be used during the study; 4. Age Requirement: Age at the time of enrollment >=1 year; 5. Platelet transfusion history: Patients with prior platelet transfusions who have a platelet count of >=50,000/microlitre without transfusion support and have not received a transfusion for at least 1 week may be enrolled; 6. Neutrophil count: In the absence of growth factor support, absolute neutrophil count = 1000/microL for 5 days; 7. Liver function indicators: (1) Total bilirubin = 50% needs to be assessed prior to treatment; 10. Lansky function state>=50%; 11. Complete recovery of toxic reactions from previous treatment; 12. Coagulation function: (1) International Normalized Ratio (INR) < 1.5; (2) Partial thromboplastin time (PTT) < 1.5 times the upper limit of normal.
Exclusion criteria
Exclusion criteria: 1. Study participants who have been receiving any antibody-based immunotherapy for less than 5 half-lives or within 30 days, or have not recovered from adverse reactions from any biologic therapy; 2. Patients who have received [131I]MIBG or Lu177-targeted nuclide therapy, and have been treated with the latest [131I]MIBG or Lu177-targeted nuclide less than 3 months; 3. Study participants less than 12 weeks after myelosuppressive therapy for autologous stem cell transplantation; 4. Study participants who have received allogeneic stem cell therapy less than 4 months from the first study dose will be excluded. For study participants who have received allogeneic stem cell therapy more than 4 months from the first study dose, they must have fully recovered and be free of active graft-versus-host disease (GVHD) to be eligible; 5. Study participants who have received radiation therapy within 2 weeks prior to the first study dose. However, study participants who have received radiation therapy at the only disease site are eligible as long as MIBG is still able to take up 2 weeks after the completion of radiotherapy; 6. Study participants who have received extensive radiotherapy (such as craniospinal cord, whole abdomen, whole lung, more than 50% bone marrow range) within 12 weeks prior to the first study dose; 7. Study participants with renal insufficiency, i.e., GFR <70 mL/min/1.73 m^2 as measured directly by creatinine clearance or radioisotope, or calculated using Schwartz's formula; 8. Pregnant or lactating females; 9. Presence of significant active infection, including active hepatitis B or hepatitis C infection, or study participants with known infection with human immunodeficiency virus (HIV) (HIV testing is not required prior to study enrollment); 10. Presence of other clinically serious diseases that may aggravate the risk of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of dose-limiting toxicities (DLTs);Incidence and severity of adverse events (AEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC);Normal organ and tumor lesions uptake activity; | — |
Countries
China
Contacts
Public ContactRong Tian
Department of Nuclear Medicine, West China Hospital of Sichuan University
Outcome results
None listed