This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.
Principal Investigator
Anne-Marie Langevin
Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu
Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu
| Arm | Description | Intervention |
|---|---|---|
Group B (clinical observation, first-line chemotherapy) | Patients undergo clinical observation for 3 years in the absence of disease progression. Upon disease progression, patients undergo surgery or receive first-line chemotherapy comprising carboplatin IV over 1 hour on day 1 (courses 1, 2, 4, 6, and 7), etoposide IV over 1 hour on days 1-3 (courses 1, 3, 4, 5, and 7), cyclophosphamide IV over 1 hour on day 1 (courses 2, 3, 5, 6, and 8), and doxorubicin hydrochloride IV over 15 minutes on day 1 (courses 2, 4, 6 and 8). Treatment with chemotherapy repeats every 21 days for 2-8 courses in the absence of disease progression or unacceptable toxicity. Once a PR or better is achieved, patients undergo clinical observation for 3 years. | Given IV Other names:
Given IV Other names:
Given IV Other names:
Optional correlative studies Undergo clinical observation Other names:
Given IV Other names:
|
Group A (clinical observation) | Patients undergo clinical observation for 96 weeks in the absence of disease progression. | Optional correlative studies Undergo clinical observation Other names:
Correlative studies |
Group C (clinical observation, first-line chemotherapy) | Patients at high risk for deterioration and a poor outcome immediately receive first-line chemotherapy as in Group B. All other patients undergo clinical observation for 3 years in the absence of disease progression. Upon disease progression, patients receive first-line chemotherapy as in Group B. Once a PR or better is achieved, patients undergo clinical observation for 3 years. | Given IV Other names:
Given IV Other names:
Given IV Other names:
Optional correlative studies Undergo clinical observation Other names:
Given IV Other names:
|