Why are we doing this research?
This study is for older children, adolescents, and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). Higher amounts of body fat is associated with resistance to chemotherapy in patients with B-ALL. Chemotherapy during the first month causes large gains in body fat in most people, even those who start chemotherapy at a healthy weight.
This study is being done to find out if caloric restriction achieved by a personalized nutritional menu and exercise plan during routine chemotherapy can make the patient's ALL more sensitive to chemotherapy and also reduce the amount of body fat gained during treatment. The goals of this study are to help make chemotherapy more effective in treating the patient's leukemia as demonstrated by fewer patients with leukemia minimal residual disease (MRD) while also trying to reduce the amount of body fat that chemotherapy causes the patient to gain in the first month.
T2020-003: A Phase 2 Randomized Trial of Caloric Restriction and Activity to Reduce Chemoresistance in B-cell Acute Lymphoblastic Leukemia.
What will happen in the study?
This research study will continue to evaluate the side effects of 131I-MIBG when treating children and adults with neuroblastoma.
- The 131I-MIBG compound is intended to work by selectively delivering the radioactive iodine to the cancer cells, which is then intended to result in their destruction.
- One treatment cycle of 131I-MIBG therapy is 7 to 9 weeks long. The patient will be evaluated to receive additional 131I-MIBG therapy at the end of each cycle. If they qualify and their blood counts are good, it is possible that they could receive a total of three treatment cycles, for a total of 21 to 27 weeks. Hospitalization is required for approximately 3-5 days after each dose.