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Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma


Title ANBL1232: Utilizing Response and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma: A Groupwide Historically Controlled Phase III Study
Therapeutic Area Neuroblastoma (pediatric)
Principal Investigator Michael Kelly, MD
Min Age 1 Years
Gender Both
Contact Jennifer Truong
617-636-8885
More Information https://clinicaltrials.gov/ct2/show/NCT02176967

Overview

In this study we are using new biologic features, in addition to the standard risk factors, to help decide which subjects need treatment and what the best treatment is. People with non-high-risk NBL generally respond well to treatment and the majority of patients can be treated successfully with standard therapy. But standard therapy can include risks from surgery and/or side effects from chemotherapy.Based on the evaluation of non-high-risk NBL patients treated in the past, we think that we can change the amount of therapy for subjects and still treat the cancer successfully. Small studies have shown that some subjects can be watched without having surgery or getting chemotherapy and still have an excellent outcome. By not having surgery or lowering the amount of chemotherapy we hope to prevent complications and harmful side effects. For other subjects we think a change in therapy will treat the cancer more successfully.

Study Details

Inclusion Criteria

  • Newly diagnosed neuroblastoma

Exclusion Criteria

  • MYCN amplified tumors

Study Requirements

Subjects in this study will have detailed biomarker analysis of their tumor and be watched closely. Depending on the characteristics of their tumor, subjects will either be watched closely or start chemotherapy. The length of chemotherapy will depend on how their tumor responds.