Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-30
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

Qualifiers

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 based on the revised INRC

Primary refractory disease

Disqualifiers

Patients who received allogeneic stem cell therapy will be excluded

Patients must have been off pharmacologic doses of systemic steroids for at least 7 days prior to enrollment. Patients who require or are likely to require pharmacologic doses of systemic corticosteroids while receiving treatment on this study are ineligible. The only exception is for patients known to require 2 mg/kg or less of hydrocortisone (or an equivalent dose of an alternative corticosteroid) as premedication for blood product administration in order to avoid allergic transfusion reactions. The use of conventional doses of inhaled steroids for the treatment of asthma is permitted, as is the use of physiologic doses of steroids for patients with known adrenal insufficiency. Patients on any other immunosuppressive medications (e.g. cyclosporine, tacrolimus) are not eligible

Patients with untreated CNS disease will be excluded. If the CNS disease has been adequately treated (e.g., surgical resection and radiation; or radiation alone) and there is no evidence of progression in the CNS, then the patient will be eligible

Patients with a history of having to permanently discontinue anti-GD2 therapy or sargarmostim (GM-CSF) due to drug-related toxicity will be excluded

Trial design

Treatments tested in this trial

  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Computed Tomography
  • Cyclophosphamide
  • Dinutuximab
  • Echocardiography Test
  • FDG-Positron Emission Tomography
  • Iberdomide
  • Magnetic Resonance Imaging
  • Multigated Acquisition Scan
  • Nuclear Radiology Imaging Procedure
  • Sargramostim
  • Topotecan

Treatment groups

76 Participants
are divided into 3 treatment groups

Locations

This trial has no locations