Chemo-Immunotherapy for High-Risk Neuroblastoma
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot be on certain medications like enzyme-inducing anticonvulsants or strong CYP3A4 inducers/inhibitors within 7 days before joining the study. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination for high-risk neuroblastoma?
Research shows that the combination of irinotecan, temozolomide, dinutuximab, and GM-CSF has demonstrated activity in patients with relapsed or refractory neuroblastoma, with response rates of up to 64% and some patients achieving complete remission. Additionally, dinutuximab combined with chemotherapy has been shown to improve survival rates in high-risk neuroblastoma patients.12345
Is the chemo-immunotherapy treatment for high-risk neuroblastoma safe for humans?
The combination of irinotecan, temozolomide, and dinutuximab with GM-CSF has been shown to be well tolerated in patients with relapsed or refractory high-risk neuroblastoma, with side effects similar to those of the individual treatments. No treatment discontinuations due to toxicities were reported, indicating a generally safe profile in the studied patients.12345
What makes this drug unique for treating high-risk neuroblastoma?
This treatment combines several drugs, including dinutuximab, which targets a specific marker (GD2) on neuroblastoma cells, with chemotherapy agents like irinotecan and temozolomide, and immune-boosting agents like sargramostim. This combination aims to improve survival rates by attacking the cancer cells directly and enhancing the body's immune response against them.12456
What is the purpose of this trial?
This phase II trial studies if dinutuximab, GM-CSF, isotretinoin in combination with irinotecan, and temozolomide (chemo-immunotherapy) can be given safely to patients with high-risk neuroblastoma after Consolidation therapy (which usually consists of two autologous stem cell transplants and radiation) who have not experienced worsening or recurrence of their disease. Dinutuximab represents a kind of cancer therapy called immunotherapy. Unlike chemotherapy and radiation, dinutuximab targets the cancer cells without destroying nearby healthy cells. Sargramostim helps the body produce normal infection-fighting white blood cells. Isotretinoin helps the neuroblastoma cells become more mature. These 3 drugs (standard immunotherapy) are already given to patients with high-risk neuroblastoma after Consolidation because they have been proven to be beneficial in this setting. Chemotherapy drugs, such as irinotecan and temozolomide, 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. They may also affect how well immunotherapy works on neuroblastoma cells. Giving chemo-immunotherapy after intensive therapy may work better in treating patients with high-risk neuroblastoma compared to standard immunotherapy.
Research Team
Ami V Desai
Principal Investigator
Children's Oncology Group
Eligibility Criteria
This trial is for patients with high-risk neuroblastoma who've completed intensive therapy without disease worsening or recurrence. Eligible participants must have finished 4-6 cycles of chemotherapy, meet specific blood count and organ function criteria, and not have had certain prior treatments like 131I-MIBG therapy or single ASCT. Pregnant women, those on immunosuppressants, or with uncontrolled infections cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive temozolomide, irinotecan, dinutuximab, sargramostim, and isotretinoin in cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dinutuximab
- Irinotecan
- Isotretinoin
- Sargramostim
- Temozolomide
Dinutuximab is already approved in United States, European Union for the following indications:
- Neuroblastoma
- High-risk neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator