124I-Humanized 3F8 for Neuroblastoma
This study is evaluating how an antibody called Hu3F8 travels through the body and to tumors.
See full descriptionAbout the trial for Neuroblastoma
Treatment Groups
This trial involves 2 different treatments. 124I-Humanized 3F8 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Eligibility
This trial is for patients born any sex of any age. You must have received 1 prior treatment for Neuroblastoma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether 124I-Humanized 3F8 will improve 1 primary outcome and 1 secondary outcome in patients with Neuroblastoma. Measurement will happen over the course of 2 years.
Patient Q & A Section
What are common treatments for neuroblastoma?
Results from a recent paper, the prognosis of stage T1 or T2 neuroblastoma patients depended significantly on non-high-risk/intermediate risk. However, neuroblastoma could often be cured with high-risk/high MYCN-intratumoral heterogeneity without surgery, which may contribute to better survival.
What causes neuroblastoma?
To our knowledge, these data indicate the first evidence of a significant increased risk of neuroblastoma in the brothers of a carrier of a germline RET mutation.
What are the signs of neuroblastoma?
All patients with NB should be tested for MYCN amplification or Ki67 index. The most specific finding is Ki67 index>or = 15%. The presence or absence of MYCN amplification is not very useful in patients less than four years old.
How many people get neuroblastoma a year in the United States?
There are no reliable statistics about neuroblastoma diagnoses in the USA. The average number of new annual cases of neuroblastoma in the US is between 10 and 12 cases. Further analysis is needed to determine the number of new cases per year.
What is neuroblastoma?
Neuroblastoma is an cancer that begins in any part of the nervous system, and accounts for 10-15% of childhood cancers in the United States. The disease tends to present as a slow-growing mass that can be benign, mildly curable, or rapidly fatal. Neuroblastoma is more likely to occur from December to June. The treatment and survival of patients remain limited: two thirds will be lost to treatment or disease progression, and 5% have a 5-year survival rate of 4%.
Can neuroblastoma be cured?
The risk of dying from the neuroblastoma is one of the highest. It is unclear whether surgery is helpful because the tumor does need to be removed to get a complete analysis of the problem. Children are prone to developing leukemia. Most of these children and their parents suffer a tremendous amount before the cancer is diagnosed. Neuroblastoma is often identified very late. Chemotherapy is not curative and the odds of cure are low. It is a disease which is notoriously difficult to cure.
Who should consider clinical trials for neuroblastoma?
There is a significant and growing interest in neuroblastoma clinical trials. The study result should be validated and its use should be integrated into neuroblastoma multimodality therapy.
How serious can neuroblastoma be?
The survival rate increases with the age at diagnosis, the stage of disease, the tumor size, the site of tumor involvement, the presence of metastasis, the amount of tumor involvement in the liver and bone marrow, the presence of tumor-induced hypertension, the presence of neuropathy or encephalopathy, the presence of hypercalcemic hypophosphatemia, and the chemotherapy. Although in most cases the prognosis is favorable, children with very high-risk disease have worse outcomes; therefore, a careful assessment of the patient's prognosis is important prior to treatment.
What is the latest research for neuroblastoma?
For treatment patients will have to continue on many drugs for a number of years unless they receive a stem cell transplant. The research isn't showing a cure will emerge for these children. The most recent drugs are chemotherapy or other medical drugs. Chemotherapy is less effective over and over and some children with neuroblastoma are taking them continuously. For the chemotherapy that do come to remission most of the body's immune systems are damaged and the brain stem is injured and can't function with the body. A stem cell transplant has been developed but it isn't proven whether it will work for all children who need it. The stem cells used are the patient's own. If the tumor cannot be completely removed the new cancer cells will be in the body.
Does 124i-humanized 3f8 improve quality of life for those with neuroblastoma?
At the 5-month point in our study, (124)I-anti-GD2 immunotox plus autologous stem cell transplantation significantly was associated with significant improvement in HRQL compared with chemotherapy with GM2 monoclonal antibody and autologous stem cell transplantation alone in adults with high-risk neuroblastoma.
What is the average age someone gets neuroblastoma?
Findings from a recent study suggest there is a strong association between age and stage at diagnosis of neuroblastoma patients, with the highest incidence of advanced disease recorded among infants and toddlers. The effect of age on treatment outcome warrants further investigation.
What is 124i-humanized 3f8?
hu3f8 is an avid and reliable antibody, but only a small portion (40%) of pediatric NB patients could be treated with it; more studies are needed to confirm this finding.