Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma
Sponsor: Children's Oncology Group
ClinicalTrials ID:NCT03126916
This study is exploring whether adding either a radioactive drug, 131I-MIBG, or a targeted therapy, lorlatinib, to standard treatment can improve outcomes for children with newly diagnosed high-risk neuroblastoma or ganglioneuroblastoma.
Patient Parameters
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Program Overview
This phase III trial is investigating if adding iobenguane I-131 (a radioactive drug) or lorlatinib (a targeted therapy) to standard treatment can help treat young patients with high-risk neuroblastoma or ganglioneuroblastoma. Iobenguane I-131 delivers radiation directly to cancer cells, while lorlatinib blocks enzymes that help cancer cells grow. The study aims to see if these additions can improve treatment outcomes compared to standard therapy alone.
Description
The main goals of this study are to see if adding iobenguane I-131 or lorlatinib to standard treatment can improve the time patients remain free from cancer events and to understand the side effects of these treatments. The study will also look at overall survival rates and how well the cancer responds to treatment. Researchers will explore how different genetic factors and tumor characteristics affect treatment outcomes.
Patients will be randomly assigned to different treatment groups, where they will receive a combination of chemotherapy drugs and possibly iobenguane I-131 or lorlatinib. The study will involve several cycles of treatment, including chemotherapy, stem cell transplants, and post-treatment care. Throughout the study, patients will undergo various tests and scans to monitor their health and the effectiveness of the treatment.
The study will also evaluate the long-term effects of the treatments, including any potential late side effects and changes in neurobehavioral outcomes. Researchers will collect data on how the treatments affect patients' quality of life and overall health over time.
Eligibility Criteria
Inclusion Criteria
- Patients must be enrolled in specific related studies before joining this trial.
- Age between 1 year and 30 years at diagnosis.
- Must have a confirmed diagnosis of neuroblastoma or ganglioneuroblastoma.
- Specific disease stages and genetic features are required for eligibility.
- Adequate kidney, liver, and heart function as determined by specific medical tests.
- No known issues that would prevent stem cell collection.
- For patients transferring from a related study, specific genetic alterations must be present, and they must be over 1 year old at the time of transfer.
Exclusion Criteria
- Patients with certain types of tumors or genetic features that do not meet the study's criteria.
- Patients with bone marrow failure syndromes.
- Patients for whom radioactive therapy is not suitable due to other medical conditions.
- Pregnant or breastfeeding females.
- Patients who are sexually active and not using effective contraception.
- Patients who have previously received certain treatments or have specific medical histories that make them ineligible.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| Phoenix Childrens Hospital | 85016 | Phoenix | Arizona |
| Arkansas Children's Hospital | 72202-3591 | Little Rock | Arkansas |
| Kaiser Permanente Downey Medical Center | 90242 | Downey | California |
| Loma Linda University Medical Center | 92354 | Loma Linda | California |
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Mattel Children's Hospital UCLA | 90095 | Los Angeles | California |
| Valley Children's Hospital | 93636 | Madera | California |
| Kaiser Permanente-Oakland | 94611 | Oakland | California |
| Children's Hospital of Orange County | 92868 | Orange | California |
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