National Cancer Institute (NCI)
This phase I/II trial studies the side effects and best dose of iberdomide when given together with chemoimmunotherapy drugs and to see how well it works in treating patients with neuroblastoma that has come back after a period of improvement (relapsed), that does not respond to treatment (refractory), or that is growing, spreading, or getting worse (progressive) following prior chemoimmunotherapy. Iberdomide is a cereblon-modulating agent. It works by helping the immune system kill tumor cells. Chemoimmunotherapy is chemotherapy combined with immunotherapy. Chemotherapy drugs, such as cyclophosphamide and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with dinutuximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Granulocyte-macrophage colony-stimulating factors (GM-CSF), such as sargramostim, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving iberdomide with chemoimmunotherapy may be safe, tolerable, and/or effective in treating patients with relapsed, refractory, or progressive neuroblastoma following prior chemoimmunotherapy.
PRIMARY OBJECTIVES: I. To identify a recommended phase 2 dose (RP2D) of iberdomide administered in combination with dinutuximab, cyclophosphamide, topotecan, and GM-CSF in patients with relapsed, refractory, or progressive neuroblastoma previously treated with chemoimmunotherapy. (Phase 1 dose escalation) II. To evaluate whether the addition of iberdomide to dinutuximab, cyclophosphamide, topotecan, and GM-CSF is associated with an improved response rate compared to dinutuximab, cyclophosphamide, topotecan, and GM CSF in patients with refractory, relapsed, or progressive neuroblastoma previou…
Inclusion Criteria: * Patients must be ≥ 1 year of age and ≤ 30 years of age at the time of study enrollment * Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines (i.e. \> 2 x upper limit of normal \[ULN\]), at the time of initial diagnosis * Progressive/relapsed or refractory (defined as persistent disease with overall response no better than minor response \[MR\] to prior therapy per revised International Neuroblastoma Response Criteria \[INRC\]) neuroblastoma…
Undergo bone marrow aspiration
Undergo bone marrow biopsy
Undergo CT
Given IV
Given IV
Undergo ECHO
Undergo FDG-PET
Given PO, NG-tube, or G-tube
Undergo MRI
Undergo MUGA
Undergo 123I-MIBG scans
Given SC or IV
Given IV