ANBL1232, Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma
Study ID: STU 072014-062
The strategy of this study is to continue a response and biology based treatment approach, but to further define patient groups using tumor biologic features and to modify therapy accordingly. new biologic markers will be evaluated on this study to classify patients. For subjects with biologically favorable tumors, we hope to avoid or reduce surgery and/or chemotherapy but still maintain current survival rates. By reducing therapy, the associated short-term and long-term side effects would be avoided. For subjects with certain symptoms or biologically unfavorable disease we believe that earlier initiation of treatment or modification of current therapy may be beneficial and improve survival. Subjects will be assigned to one of three treatment groups (designated as Group a, B or C) based on the patient's age, tumor stage and tumor characteristics. The goal of this study is to determine whether the overall survival (oS) rates observed on previous studies can be improved or maintained through modification or reduction in treatment. oS was the endpoint for prior intermediate risk neuroblastoma studies a3961 and anBL0531 so we will be better able to compare the results of this study to those prior trials. all subjects will be monitored during the study to detect early signs of potential problems in the change in treatment strategy. Group a: Subjects will not have surgery, but will have frequent tests to watch for tumor growth or spread to other parts of the body. if the tumor does not get bigger or spread, subjects will be observed for 96 weeks. if at any time the tumor grows or spreads, subjects will stop taking part in this trial and surgery may be recommended. Group B: Subjects will not receive chemotherapy or surgery at first, but will be closely observed for 8 weeks. if the tumor does not get bigger or spread subjects will be observed for 3 years. if the tumor does grow subjects will start treatment. Treatment will continue until the tumor gets at least 50% smaller, then therapy would stop and subjects go back to being observed. Group C: Subjects less than 3 months of age and those with symptoms or unfavorable tumor biology will start chemotherapy immediately. Response and a symptom scoring system will be used to decide when to stop therapy. The scoring system will assign a number value to certain symptoms. The amount of chemotherapy given to each subject will depend upon their response to therapy and symptom score. Subjects without symptoms or those with good biology features will not get chemotherapy immediately but will be observed with frequent evaluations. if symptoms do not develop, subjects will be observed for up to 3 years. if symptoms do develop, the symptom scoring system will be used to decide when to start and when to stop chemotherapy.
* Patient must have newly diagnosed neuroblastoma as defined in the protocol and meet the criteria for one of the four treatment groups defined in protocol Section 3.2.3. In summary: Group A Patients < 12 months (< 365 days) of age with newly diagnosed Stage L1 neuroblastoma. Group B Patients < 18 months (< 547 days) of age with newly diagnosed Stage L2 neuroblastoma. Group C Patients < 18 months (< 547 days) of age with newly diagnosed Stage Ms neuroblastoma.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- Tanya Carens Watt
CHILDRENS ONCOLOGY GROUP OPERATIONS CTR
Brain and Nervous System; Unknown Sites