Study on Adding Iberdomide to Treatment for Neuroblastoma That Has Returned, Not Responded, or Worsened
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT07437963
This clinical trial is exploring whether adding a new drug, iberdomide, to existing chemoimmunotherapy can help treat neuroblastoma that has come back, not responded to treatment, or gotten worse. The study aims to find the best dose and see if this combination is safe and effective.
Patient Parameters
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Program Overview
This study is testing a new treatment approach for neuroblastoma, a type of cancer that affects nerve cells. The trial is looking at whether adding a drug called iberdomide to standard chemoimmunotherapy can help patients whose cancer has returned, not responded to previous treatments, or worsened. Iberdomide is thought to help the immune system attack cancer cells. The study will determine the best dose of iberdomide and evaluate its safety and effectiveness when combined with other cancer drugs.
Description
The study is divided into two phases. In Phase I, researchers will determine the safest and most effective dose of iberdomide when combined with other cancer treatments like dinutuximab, cyclophosphamide, topotecan, and GM-CSF. In Phase II, the study will compare the effectiveness of this combination with the standard treatment without iberdomide.
Participants will receive iberdomide along with chemotherapy and immunotherapy drugs. The treatment cycles repeat every 28 days for up to 12 cycles, as long as the cancer does not progress and side effects are manageable.
Throughout the study, participants will undergo various tests, including heart scans, bone marrow tests, and imaging scans, to monitor their health and the treatment's impact on the cancer. After completing the treatment, participants will have follow-up visits to check their health and any long-term effects of the treatment.
The study aims to improve treatment outcomes for patients with neuroblastoma that has returned, not responded, or worsened after previous treatments.
Eligibility Criteria
Inclusion Criteria
- Aged between 1 and 30 years old.
- Diagnosed with neuroblastoma or ganglioneuroblastoma, confirmed by tests.
- Cancer must have returned, not responded, or worsened after previous treatments.
- Must have measurable or evaluable disease based on specific medical criteria.
- Must have received one prior chemoimmunotherapy regimen.
- Must have recovered from previous treatments and meet specific health criteria, including blood counts and organ function.
- Must not have received certain treatments or medications within specified timeframes before joining the study.
- Must agree to use effective contraception if of childbearing potential.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Have received allogeneic stem cell therapy.
- Require systemic steroids or other immunosuppressive medications.
- Have untreated central nervous system disease.
- Have a history of severe allergic reactions to study drugs.
- Have other types of cancer or serious medical conditions.
- Have prior exposure to iberdomide or similar drugs.
- Cannot tolerate oral medications or have significant absorption issues.
- Have uncontrolled infections or significant peripheral neuropathy.
- Are pregnant or breastfeeding.
- Do not agree to use effective contraception if of reproductive potential.
- Have not signed a consent form.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Oncology Group | 94607 | Oakland | California |
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