CLINICAL TRIAL

124I-Humanized 3F8 for Neuroblastoma

Waitlist Available · Any Age · All Sexes · New York, NY

This study is evaluating how an antibody called Hu3F8 travels through the body and to tumors.

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About the trial for Neuroblastoma

Eligible Conditions
Sarcoma · Melanoma · 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
124I-Humanized 3F8
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Stage 4 disease that has either relapsed or has not responded to treatment (refractory stage) is classified as MYCN-amplified type 2B or 3. show original
Melanoma
Ewing sarcoma
Spindle cell sarcoma
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

PET/CT scan images will be analyzed to determine bio distribution of 124I-hu3F8
2 YEARS
124I-hu3F8 will be injected IV followed by PET/CT scans at serial timepoints PET/CT scan images will be analyzed to determine biodistribution of 124I-hu3F8
radioactivity measured to determine pharmacokinetics of 124I-hu3F8
2 YEARS
Following 124I-hu3F8 administration, upon completion of normal saline flush, blood will be drawn for pharmacokinetic studies at the following time points: 0h, 0.5h, 1h, 2h, 4-8h, 24h, 48h, 96h and 120-144 h.after injection of 124I-hu3F8 and radioactivity measured to determine pharmacokinetics of 124I-hu3F8.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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%.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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