Neuroblastoma (NB)
Conditions
Keywords
Radiopharmaceutical
Brief summary
Fractionated dosing of \[211At\]MABG Radiotherapy in Relapsed/Refractory Neuroblastoma
Detailed description
Fractionated dosing of \[211At\]MABG Radiotherapy in Relapsed/Refractory Neuroblastoma
Interventions
DRUG[211At]MABG
Fractionated Dose
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with MIBG avid lesions, high-risk neuroblastoma per the Revised International Neuroblastoma Response Criteria (Revised INRC), with refractory, relapsed, or progressive disease. 2. All measurable soft tissue lesions must be MIBG-avid. 3. Age ≥ 1 year at enrollment. 4. Lansky performance status ≥ 50%. 5. Adequate organ function and hematologic parameters.
Exclusion criteria
1. Antibody-based immunotherapy within fewer than 5 half-lives or 30 days (whichever is shorter), or who have not yet recovered from adverse effects of any biologic therapy. 2. Treatment with \[¹³¹I\]MIBG or Lu177 targeted radionuclide therapy less than 3 months of last administration. 3. Autologous stem cell transplant \<12 weeks, or Allogeneic stem cell transplant \<4 months (patients \>4 months post-transplant must be free of active GVHD). 4. Radiotherapy within 2 weeks prior to the first study dose (However, patients with a single-site irradiation that remains MIBG avid may be enrolled.) or extensive-field radiotherapy (e.g., craniospinal, whole abdomen, whole lung, or \>50% of bone marrow area) within 12 weeks prior to the first study dose. 5. Renal Insufficiency. 6. Active Infections.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of dose-limiting toxicities (DLTs) | From administration of [211At]MABG until 4 weeks after injection | Incidence and severity of dose-limiting toxicities (DLTs) |
| Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0 | From administration of [211At]MABG until 4 weeks after last dose of injection | Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) | 8 weeks after [211At]MABG administration, Participants without disease progression (PD) will be evaluated every 8 weeks for the first 24 weeks, then every 12 weeks until PD, new cancer therapy, death, or study termination | Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) |
| Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry | About 21hours from time of [211At]MABG administration] | Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry |
Countries
China
Contacts
CONTACTRong TIAN, MD
CONTACTXiaoao WU, PHD
PRINCIPAL_INVESTIGATORRong TIAN, MD
West China Hospital
Outcome results
None listed