Phase II STING Trial: Testing a New Treatment for High-Risk Neuroblastoma
Sponsor: New Approaches to Neuroblastoma Therapy Consortium
ClinicalTrials ID:NCT06450041
This clinical trial is exploring a new treatment approach for high-risk neuroblastoma that has returned or not responded to previous treatments. The study combines four medicines with special immune cells to see if it can improve outcomes for patients.
Patient Parameters
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Program Overview
The study is testing a combination of four medicines—dinutuximab, temozolomide, irinotecan, and GM-CSF—along with special immune cells called NK cells to treat high-risk neuroblastoma. Dinutuximab targets neuroblastoma cells, while temozolomide and irinotecan are chemotherapy drugs. GM-CSF boosts the immune system. NK cells are a type of immune cell that can attack cancer cells, but in this study, they are specially prepared to work better against neuroblastoma. The trial aims to see if this combination can be more effective than current treatments.
Description
High-risk neuroblastoma is a challenging cancer to treat, especially when it returns or doesn't respond to initial treatments. This study is testing a new combination of treatments to see if it can improve outcomes for patients. The treatment includes four medicines: dinutuximab, which targets neuroblastoma cells; temozolomide and irinotecan, which are chemotherapy drugs; and GM-CSF, which helps boost the immune system. Additionally, the study uses special NK cells that are prepared to be more effective against neuroblastoma. These NK cells are donated and specially treated to resist the cancer's defenses. Patients will receive the chemotherapy drugs for five days, with dinutuximab added on days 2-5. If tolerated, the special NK cells will be given on day 8. This treatment can be repeated for up to six cycles.
Eligibility Criteria
Inclusion Criteria
- Age between 1 and 31 years.
- Diagnosed with neuroblastoma, confirmed by tests or tumor cells in the bone marrow.
- Classified as high-risk neuroblastoma.
- Must have one of the following:
- Disease that has returned or progressed after initial treatment.
- Refractory disease, meaning no response after at least four courses of initial therapy.
- Persistent disease, meaning partial response after at least four courses of initial therapy.
- Must have measurable disease, such as bone, bone marrow, or soft tissue involvement.
- Must have a performance score of 50 or higher, indicating ability to perform daily activities.
- Must have recovered from previous treatments and meet specific blood, kidney, liver, heart, and lung function criteria.
- Must not have received certain treatments within specified timeframes before joining the study.
- Females of childbearing potential must have a negative pregnancy test and agree to use contraception.
Exclusion Criteria
- Pregnant or breastfeeding individuals, or those unwilling to use contraception.
- Individuals unable to comply with study requirements.
- Individuals with major organ disease that affects treatment tolerance.
- Individuals with severe diarrhea.
- Individuals who have had a prior stem cell or organ transplant.
- Individuals on dialysis.
- Individuals with active or uncontrolled infections.
- Individuals with a history of HIV, hepatitis B, or hepatitis C.
- Individuals with other cancers.
- Individuals with severe allergic reactions to similar treatments.
- Individuals with disease progression on specific previous therapies.
- Individuals on systemic steroids or immunosuppressive medications, with some exceptions for low doses or specific conditions.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital Los Angeles | 90027-0700 | Los Angeles | California |
| UCSF Benioff Children's Hospital | 94143 | San Francisco | California |
| Children's Hospital Colorado | 80045 | Aurora | Colorado |
| Comer Children's Hospital, University of Chicago | 60614 | Chicago | Illinois |
| Boston Children's Hospital, Dana-Farber Cancer Institute. | 02115 | Boston | Massachusetts |
| C.S Mott Children's Hospital | 48109 | Ann Arbor | Michigan |
| Cincinnati Children's Hospital Medical Center | 45229-3039 | Cincinnati | Ohio |
| Nationwide Children's Hospital | 43205 | Columbus | Ohio |
| Children's Hospital of Philadelphia | 19104-4318 | Philadelphia | Pennsylvania |
| St. Jude Children's Research Hospital | 38105 | Memphis | Tennessee |
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