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Radiopharmaceutical
MIBG + Dinutuximab Therapy for Neuroblastoma
Phase 1
Waitlist Available
Research Sponsored by New Approaches to Neuroblastoma Therapy Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines
All patients must have at least one of the following: Recurrent/progressive disease after the diagnosis of high-risk neuroblastoma at any time prior to enrollment regardless of response to frontline therapy, refractory disease with a best overall response of no response/stable disease since diagnosis of high-risk neuroblastoma and at least 4 cycles of induction therapy, persistent disease with a best overall response of no partial response since diagnosis of high-risk neuroblastoma and at least 4 cycles of induction therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all toxicities from enrollment until completion of course 1 (day 56)
Awards & highlights
Study Summary
This trial is testing a new therapy for neuroblastoma, which is a cancer that primarily affects children. The therapy is a combination of two drugs, and the goal of the trial is to determine the best dose of the two drugs to give to patients. If the therapy is well tolerated, a third drug will be added to the trial.
Who is the study for?
This trial is for pediatric patients with high-risk neuroblastoma, a type of cancer. They must have evidence of MIBG uptake in tumors or increased urinary catecholamines and meet specific criteria regarding their disease state (recurrent/progressive, refractory, persistent). Participants need to be recovered from prior treatments and have adequate organ function. Pregnant individuals or those unable to follow the study plan are excluded.Check my eligibility
What is being tested?
The trial tests a combination therapy using 131I-MIBG with dinutuximab for children with neuroblastoma that's resistant or has come back after treatment. If safe, vorinostat will be added at a certain dose level. The study uses a 'rolling 6' design to find the best dose for phase 2 trials and includes additional patient groups to confirm findings.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation by dinutuximab such as pain, fever, allergic responses; thyroid issues due to potassium iodide; blood cell changes from sargramostim; and fatigue or digestive problems from vorinostat.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with neuroblastoma confirmed by tests.
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My high-risk neuroblastoma has not improved after initial treatments.
Select...
I have a lesion from neuroblastoma or ganglioneuroblastoma that can't be measured but was confirmed by biopsy or is MIBG avid.
Select...
I am expected to live at least 12 weeks and can do some daily activities on my own.
Select...
I have recovered from side effects of my previous cancer treatments.
Select...
I have a tumor that can be measured and fits specific size criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ all toxicities from enrollment until completion of course 1 (day 56)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all toxicities from enrollment until completion of course 1 (day 56)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Describe Non Hematological Toxicities Cohort B
Describe Non-Hematological Toxicities Cohort A
MTD/RP2D determination Cohort A
+1 moreSecondary outcome measures
Overall Response Cohort A
Overall Response Cohort B
Side effects data
From 2021 Phase 2 trial • 114 Patients • NCT0203513792%
10035528-Platelet count decreased
89%
10002272-Anemia
89%
10029366-Neutrophil count decreased
84%
10049182-White blood cell decreased
71%
10025256-Lymphocyte count decreased
61%
10003481-Aspartate aminotransferase increased
55%
10001551-Alanine aminotransferase increased
39%
10047700-Vomiting
37%
10021038-Hyponatremia
37%
10028813-Nausea
32%
10011224-Cough
29%
10016256-Fatigue
26%
10002646-Anorexia
26%
10016558-Fever
21%
10021018-Hypokalemia
21%
10020943-Hypoalbuminemia
21%
10020949-Hypocalcemia
18%
10001675-Alkaline phosphatase increased
18%
10021059-Hypophosphatemia
18%
10000081-Abdominal pain
18%
10010774-Constipation
18%
10019211-Headache
18%
10020639-Hyperglycemia
18%
10021028-Hypomagnesemia
16%
10020670-Hypermagnesemia
13%
10006002-Bone pain
13%
10028735-Nasal congestion
11%
10012727-Diarrhea
11%
10001723-Allergic rhinitis
11%
10040752-Sinus tachycardia
11%
10041367-Sore throat
8%
10006504-Bruising
8%
10033425-Pain in extremity
8%
10000636-Activated partial thromboplastin time prolonged
8%
10003988-Back pain
8%
10005364-Blood bilirubin increased
8%
10013786-Dry skin
8%
10020772-Hypertension
8%
10028836-Neck pain
8%
10046571-Urinary tract infection
5%
10002855-Anxiety
5%
10015090-Epistaxis
5%
10025482-Malaise
5%
10034960-Photophobia
5%
10016288-Febrile neutropenia
5%
10007810-Catheter related infection
5%
10013781-Dry mouth
5%
10013963-Dyspnea
5%
10014222-Edema face
5%
10019450-Hematuria
5%
10020587-Hypercalcemia
5%
10020647-Hyperkalemia
5%
10022402-INR increased
5%
10031009-Oral pain
5%
10033371-Pain
5%
10034310-Penile pain
5%
10037087-Pruritus
5%
10062225-Urinary tract pain
3%
HYPERPHOSPHATEMIA
3%
10040741-Sinus bradycardia
3%
10056910-GGT increased
3%
PAIN, LEG
3%
10046300-Upper respiratory infection
3%
10016778-Floaters
3%
10016791-Flu like symptoms
3%
10059827-Rhinitis infective
3%
10050068-Edema limbs
3%
10062466-Localized edema
3%
10066874-Gastroesophageal reflux disease
3%
ADJUSTMENT DISORDER
3%
CONCERN FOR DISEASE PROGRESSION AS INDICATED BY INTERVAL INCREASE IN THE SIZE OF HER OCCIPITAL MASS
3%
DYSURIA
3%
PAPULOERYTHEMATOUS LESIONS - LEFT CHEEK
3%
10002167-Anal pain
3%
10045158-Tumor pain
3%
10048994-Bladder spasm
3%
10021143-Hypoxia
3%
10013573-Dizziness
3%
10013946-Dyspepsia
3%
10015958-Eye pain
3%
10034620-Peripheral sensory neuropathy
3%
10000060-Abdominal distension
3%
INJURY TO LEFT WRIST
3%
10035598-Pleural effusion
3%
RHINORRHEA
3%
PILONIDAL CYST
3%
10005886-Blurred vision
3%
10007839-CD4 lymphocytes decreased
3%
10011368-Creatinine increased
3%
10014020-Ear pain
3%
10020039-Hiccups
3%
10020680-Hypernatremia
3%
10020870-Hypertriglyceridemia
3%
10021005-Hypoglycemia
3%
10021097-Hypotension
3%
10021114-Hypothyroidism
3%
10022437-Insomnia
3%
10022998-Irritability
3%
10024264-Lethargy
3%
10028130-Mucositis oral
3%
10037868-Rash maculo-papular
3%
10038064-Rectal hemorrhage
3%
10040872-Skin infection
3%
10044055-Toothache
3%
10047900-Weight loss
3%
10051792-Infusion related reaction
3%
10065973-Iron overload
3%
ENTEROBACTER CLOACAE
3%
PARAPHIMOSIS
3%
PAROTIDITIS
3%
RHINOVIRUS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single-Agent 131I-MIBG
131I-MIBG With Vincristine/Irinotecan
131I-MIBG With Vorinostat
Trial Design
2Treatment groups
Experimental Treatment
Group I: 131I-MIBG with Dinutuximab and VorinostatExperimental Treatment5 Interventions
Patients will receive vorinostat on days 0-13. 131I-MIBG will be received on day 1. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy. Dinutuximab and 131I-MIBG dose will be based on the dose level assigned at the time of patient registration. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy
Group II: 131I-MIBG with DinutuximabExperimental Treatment4 Interventions
Patients will receive 131I-MIBG on day 1. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy. Dinutuximab and 131I-MIBG dose will be based on the dose level assigned at the time of patient registration. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Potassium Iodide
FDA approved
131I-MIBG
2005
Completed Phase 2
~220
Dinutuximab
FDA approved
Vorinostat
2014
Completed Phase 3
~1600
Sargramostim
FDA approved
Find a Location
Who is running the clinical trial?
New Approaches to Neuroblastoma Therapy ConsortiumLead Sponsor
16 Previous Clinical Trials
1,589 Total Patients Enrolled
16 Trials studying Neuroblastoma
1,589 Patients Enrolled for Neuroblastoma
United TherapeuticsIndustry Sponsor
107 Previous Clinical Trials
13,342 Total Patients Enrolled
6 Trials studying Neuroblastoma
139 Patients Enrolled for Neuroblastoma
Thomas Cash, MDStudy ChairChildren's Healthcare of Atlanta
2 Previous Clinical Trials
113 Total Patients Enrolled
1 Trials studying Neuroblastoma
53 Patients Enrolled for Neuroblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving hemodialysis.I have chosen not to participate in the NANT 2004-05 study.I have had anti-GD2 therapy but not with 131I-MIBG.My cancer shows MIBG uptake in at least one site, confirmed within the last 28 days.I have been diagnosed with neuroblastoma confirmed by tests.My neuroblastoma is classified as high-risk according to COG.I haven't had certain treatments recently.I have never stopped anti-GD2 therapy because of side effects.I have a lesion from neuroblastoma or ganglioneuroblastoma that can't be measured but was confirmed by biopsy or is MIBG avid.My organs are functioning well.My high-risk neuroblastoma has not improved after initial treatments.I have never had total body irradiation.I have had a stem cell transplant from a donor.I have a history of HIV, hepatitis B, or hepatitis C.I am expected to live at least 12 weeks and can do some daily activities on my own.I have recovered from side effects of my previous cancer treatments.My major organs are healthy enough to handle treatment.I have been treated with an HDAC inhibitor and 131I-MIBG together.I have a tumor that can be measured and fits specific size criteria.I do not have any ongoing or uncontrolled infections.
Research Study Groups:
This trial has the following groups:- Group 1: 131I-MIBG with Dinutuximab
- Group 2: 131I-MIBG with Dinutuximab and Vorinostat
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have other experiments employed 131I-MIBG to analyze its effects?
"Currently, there are 49 active clinical trials researching 131I-MIBG with 6 in Phase 3. Sioux Falls, South dakota is hosting several of these studies and 1732 facilities across the country have opened their doors to them."
Answered by AI
How widespread is the application of this trial?
"This clinical trial is accepting patients from Children's Hospital and Regional Medical Center - Seattle in Seattle, Washington; University of Chicago, Comer Children's Hospital in Chicago, Illinois; and Children's Hospital of Philadelphia in Philadelphia, Pennsylvania as well as 11 additional locations."
Answered by AI
How many participants is the research team enrolling in this trial?
"United Therapeutics is coordinating this trial from locations such as Children's Hospital and Regional Medical Center - Seattle in Seattle, Washington and University of Chicago, Comer Children's Hospital in Chicago. To initiate the study, 50 participants who meet the qualifications for inclusion must be recruited."
Answered by AI
Does this clinical trial encompass individuals aged 65 or older?
"Data from this clinical trial shows that only those between 1 and 30 years old can enroll. There are 185 studies for younger patients, while elder people have 68 trials to choose from."
Answered by AI
Does this examination accept participants at present?
"Affirmative. Per the information found on clinicaltrials.gov, this medical study is currently recruiting participants for enrollment with 50 volunteers needed from 11 different hospitals in order to complete the trial which was initially launched on September 12th 2018 and lastly updated on May 5th 2022."
Answered by AI
What potential hazards are associated with 131I-MIBG treatment?
"Due to the limited clinical evidence available, our team assigned 131I-MIBG a score of 1 on our safety scale. This reflects its Phase 1 status and lack of data exhibiting efficacy or safety."
Answered by AI
What primary goals is the research team hoping to accomplish with this clinical trial?
"The primary aim of this project, which will span a period of 24 months, is to evaluate and report on the adverse effects associated with 131I-MIBG in conjunction with dinutuximab. Secondary outcomes include evaluating bone response through MIBG scans for avid tumors and FDG-PET scans for non-avid tumours via Curie scoring, assessing soft tissue response using RECIST criteria alongside MIBG/FDG PET avidity/biopsy results, as well as determining the proportion of patients who experienced complete remission (CR), CR minus minimal disease (CR-MD) or partial remission (PR)."
Answered by AI
To whom is enrollment in this clinical trial available?
"This medical study is seeking 50 participants with a diagnosis of neuroblastoma and being between 1 Year to 30 Years."
Answered by AI
To what ailments is 131I-MIBG therapeutically employed?
"131I-MIBG is an effective therapeutic course for treating lymphoma, t-cell variants of the disease, high risk neuroblastomas, and progressive cutaneous t-cell lymphoma."
Answered by AI
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