CLINICAL TRIAL

Hu3F8 for Neuroblastoma

Metastatic
Stage II
Waitlist Available · Any Age · All Sexes · New York, NY

This study is evaluating whether a drug called Hu3F8 plus GM-CSF can prevent your neuroblastoma from growing.

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About the trial for Neuroblastoma

Treatment Groups

This trial involves 2 different treatments. Hu3F8 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Isotretinoin
DRUG
GM-CSF
DRUG
Hu3F8
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isotretinoin
FDA approved
GM-CSF
2014
Completed Phase 4
~1340

Eligibility

This trial is for patients born any sex of any age. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Diagnosis of NB as defined by a) histopathology (confirmed by the MSK Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.
Patients must have high-risk NB (MYCN-amplified stage 2/3/4/4S of any age and MYCN-nonamplified stage 4 in patients greater than 18 months of age).
Patients must be in first CR/VGPR
Patients must have a negative human anti-hu3F8 antibody (HAHA) titer
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Odds of Eligibility
High>50%
You meet most of the criteria! It's probably a good idea to apply to 1 other trial just in case this doesn't work out.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
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 Hu3F8 will improve 1 primary outcome in patients with Neuroblastoma. Measurement will happen over the course of 2 years.

relapse-free survival (RFS)
2 YEARS
Patients are considered a response failure under this protocol if progressive disease is evident before two years. Deaths from toxicity attributable to protocol treatment will be counted as events. Patients who withdraw or are lost to followup before two years will be considered as progressions.
2 YEARS

Patient Q & A Section

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

Have there been other clinical trials involving hu3f8?

Although it seems that more clinical trials are needed, hu3f8 could be an alternative (or part of) the therapeutic approach in future study. Further clinical trials, involving hu3f8 are now warranted.

Anonymous Patient Answer

Has hu3f8 proven to be more effective than a placebo?

In a recent study, findings did not reveal a superiority of Hu3f8 over a placebo. In a recent study, findings provided no support for the use of Hu3f8 in the treatment of advanced neuroblastoma.

Anonymous Patient Answer

How many people get neuroblastoma a year in the United States?

One study has estimated the annual incidence rate to be 4.5 cases per 10,000 live births; another suggests that the incidence from birth in US is 2.25 per 10,000 live births. Both studies include some uncertainties. One study also suggests that males are more commonly affected than females and that they develop the tumor much farther back in the body tissue and at a younger age. The incidence rates from birth in different ethnic groups are unknown. We find some general trends and use one study to suggest that the incidence rate for children under five is 3.0 per 10,000 live births, a small increase over the incidence rate in children under one year of age.

Anonymous Patient Answer

What causes neuroblastoma?

There is no identifiable cause for neuroblastoma, and there is often no obvious environmental trigger. Genetic factors do not cause neuroblastoma, neither does breastfeeding. answer: [supplied by OMIM]\n\nDiabetes mellitus (DM) is a disease of the insulin-producing cells of the pancreas. It often occurs in the context of an abnormal lipid metabolism and is a major risk factor for cardiovascular disease. In recent years, a link between DM and cancer growth has also been described. For example, the number of people with diabetes in the United States is now in the over 20 million range, but the incidence of cancer in the United States has declined.

Anonymous Patient Answer

What is neuroblastoma?

Neuroblastoma is the third most common cancer in children and is the most common cancer in neonates. The median age at diagnosis in children is 18-21 months. It is also the second most common cause of death in children <1 year of age. Neuroblastoma can occur in any part of the body but tends to affect children between 6 and 10 months.\n

Anonymous Patient Answer

What are common treatments for neuroblastoma?

In most pediatric patients neuroblastoma is a curable disease. There are significant differences between adult and pediatric management strategies, including surgery in pediatric patients and, in general, radiotherapy in adults.

Anonymous Patient Answer

What are the signs of neuroblastoma?

A physical examination of the neck and extremities is necessary in every examination of a child with this condition. The absence of cervical or inguinal lymph nodes indicates a lack of dissemination of neuroblasts to distant sites. The presence of these nodes suggests dissemination has already occurred. Other less-common symptoms may be specific to stage or type of neuroblastoma. Most manifestations of stage 4 neuroblastoma are related to an underlying bone involvement or the increased circulating tumor mass caused by the metastatic disease. Some signs and symptoms of disseminated neuroblastoma disseminated from the bone may include bone pain, altered sensations in the extremities (asthenia), anemia, fever, and jaundice.

Anonymous Patient Answer

Can neuroblastoma be cured?

Neuroblastomas can be cured and can recur. Survival after cure can vary depending on the stage at which the tumor was diagnosed and the type of treatment administered.

Anonymous Patient Answer

What is the survival rate for neuroblastoma?

The survival rate for older children with Stage 4 and 5 tumors is improved when they have no evidence of disease and when it can be detected at an early stage of disease, so that surgical removal can be possible, but the survival time of this group is significantly shorter than the survival for children who have a stage 4 or 5 neuroblastoma and no evidence that the disease is metastatic.

Anonymous Patient Answer

What does hu3f8 usually treat?

Hu3f8 has been shown to block neuronal differentiation and have cell death effects. In a recent study, findings are not only in the test tube but in the body as well. Hu3f8 is toxic to the body, causing immune responses and apoptosis. Hu3f8's ability to cause apoptosis also makes it an attractive agent for neuroblastoma research.

Anonymous Patient Answer

What is hu3f8?

Hu3f8 protein is a homogeneous 30.0 kD glycoprotein in normal fetal and adult nervous system. It is abundantly expressed in various tissues and functions as a secreted/membrane protein. These properties are properties of neural cell lines used in research. There is no evidence that hu3f8 is widely expressed during neurogenesis.

Anonymous Patient Answer

Have there been any new discoveries for treating neuroblastoma?

There hasn't been any cure for neuroblastoma. A small minority of children with stage 4 neuroblastoma can survive a number years, so a cure is probably not in the near future.

Anonymous Patient Answer
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