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Treatment (131I-MIBG, chemotherapy) for Neuroblastoma
Study Summary
This trial is studying MIBG therapy and chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I haven't had high-dose radiation to my kidneys or liver.I am breastfeeding but agree to stop if I join the trial.I am older than 18 months and my cancer has unfavorable pathology.I am over 1 year old with a specific type of stage 2 neuroblastoma.I've had limited treatment for neuroblastoma, following specific protocols.My creatinine level is equal to or less than 1.2 mg/dL, and I am between 10 and 13 years old.My kidney function is within the normal range for my age and gender.My bilirubin levels are within the normal range for my age.My kidney function tests are within normal range for my age and gender.My neuroblastoma is newly diagnosed and classified as stage 4.My cancer shows a specific genetic change and I am over 1 year old.My cancer progressed to stage 4 without chemotherapy after initial diagnosis.My child's bilirubin level is less than or equal to 1.0 mg/dL.My liver enzymes are within normal limits for my age.My child is 1-1.5 years old with specific unfavorable cancer features or unknown cancer features.My cancer shows a high level of MYCN and I am over 1 year old.My kidney function, based on creatinine levels, is within the normal range.I am older than 18 months.My child's bilirubin level is less than or equal to 0.8 mg/dL.I have been diagnosed with neuroblastoma or ganglioneuroblastoma.My child is 12-18 months old with stage 4 neuroblastoma but does not qualify due to favorable factors.My bilirubin levels are within the required range for my age.My condition is newly diagnosed stage 3 neuroblastoma.
- Group 1: Treatment (131I-MIBG, chemotherapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this investigation a pioneering medical experiment?
"This pharmacological study has been under investigation since 1997, when it was first sponsored by Alfacell. After the initial trial in '97 involving 300 participants, this medication obtained its Phase 3 approval. Nowadays, 1811 trials are being conducted regarding this drug and taking place across 80 countries and 3779 cities worldwide."
What illnesses are typically targeted with pharmaceutical research?
"This pharmacological study is known for its efficacy in treating Merkel cell cancer and has been used to combat leukemia, prostate cancer, and several types of lung cancers."
How many healthcare facilities are currently implementing this clinical trial?
"Currently, 23 clinical trial sites are operating for this medical study. These locations span from Madison and Milwaukee to Birmingham as well as 20 other cities. To minimize travelling needs, patients should try to select the closest site if they decide to partake in this research."
Could you elaborate on any prior investigations that have explored medication-based research?
"Research into this medication began in 1997 at Spectrum Health Hospital - Butterworth Campus, and 3719 trials have successfully concluded. Currently, 1811 studies are actively recruiting participants, with a large number of them based out of Madison, Wisconsin."
Does this clinical trial accommodate patients above the age of 40?
"Eligibility for this trial is restricted to individuals aged 1-30 years. There are 592 trials open to participants under 18, and 1547 studies with a minimum age requirement of 65+."
Are candidates able to apply for this clinical trial at the present moment?
"According to the data available on clinicaltrials.gov, this medical study is not actively recruiting patients at this time; however, it was initially posted in October 2010 and last updated March 3rd 2022. For those seeking alternative studies, there are a total of 1973 trials currently looking for candidates."
How many participants are recruited for this investigation?
"This trial is no longer accepting patients. It was initiated on October 1st, 2010 and last updated on March 3rd 2022. If you are searching for other studies related to ganglioneuroblastoma, there are 162 trials currently available; if interested in pharmacological research, 1811 trails have openings for participants."
What criteria must potential participants meet to qualify for enrollment in this trial?
"This medical trial is actively recruiting up to 99 participants between the ages of one year and 30 who have been diagnosed with ganglioneuroblastoma. Eligible patients must meet the following criteria: 365 days post initial diagnosis, INSS stage 1-4S progression without chemotherapy, enrolled in ANBL00B1 within 4 weeks of progressing to Stage 4 regardless of biologic features; 12-18 months age range with any 3 unfavorable biological characteristics (MYCN amplification, poor pathology report/DNA index = 1) or indeterminate/unsatisfactory/unknown biology; MYCN amplification (>4 fold increase); 18+ months old with"
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