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Radioactive Agent
Iobenguane (131-I) + Vorinostat for Neuroblastoma (OPTIMUM Trial)
Phase 2
Recruiting
Research Sponsored by Jubilant DraxImage Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Cumulative lifetime dose of 131I-MIBG at enrollment does not exceed 18 mCi/kg.
All soft tissue lesions identified on CT/MRI scans must be iobenguane avid lesions on an (123I)-iobenguane scan, or
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for all tumour assessment data collected throughout the study (up to the end of the 2-year follow-up)(131i-mibg + vorinostat).
Awards & highlights
OPTIMUM Trial Summary
This trial is testing a new combination treatment for neuroblastoma, a type of cancer that most often affects children. The treatment consists of a targeted radiation therapy called 131I-MIBG, which is used to deliver a high dose of radiation directly to the tumor, and Vorinostat, which is a type of chemotherapy.
Who is the study for?
This trial is for patients with high-risk neuroblastoma that's come back or gotten worse. They should have recovered from previous treatments, not exceeded a certain dose of 131I-MIBG therapy, and have specific organ functions within normal ranges. Patients must be over 1 year old, able to perform daily activities at least half the time (Karnofsky/Lansky score ≥50%), and agree to use effective contraception if applicable.Check my eligibility
What is being tested?
The study tests how safe and effective the combination of two drugs, Iobenguane (131-I) and Vorinostat, is in treating recurrent or progressive high-risk neuroblastoma. It looks at whether this combo can help patients whose cancer has returned or continued to grow despite treatment.See study design
What are the potential side effects?
While the trial description doesn't list specific side effects, similar therapies often cause nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. There may also be kidney or liver function changes and potential thyroid issues.
OPTIMUM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received less than 18 mCi/kg of 131I-MIBG in my lifetime.
Select...
My scans show that my cancer takes up a specific dye.
Select...
I have enough stored stem cells for the study.
Select...
I have high-risk neuroblastoma that has come back or gotten worse despite treatment.
Select...
My liver tests are within the required range.
Select...
My biopsy showed a growing tumor is not neuroblastoma.
Select...
I can do most activities by myself, regardless of my age.
Select...
I received 131I-MIBG therapy alone, not with other cancer drugs.
OPTIMUM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for all tumour assessment data collected throughout the study (up to the end of the 2-year follow-up)(131i-mibg + vorinostat).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for all tumour assessment data collected throughout the study (up to the end of the 2-year follow-up)(131i-mibg + vorinostat).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response
Secondary outcome measures
Durability of Effect of Overall Response (Yes/No)
Durability of Effect of Relative Curie Extension Score
Overall Response at 6 weeks after 131I-MIBG treatment
+1 moreOther outcome measures
Incidence of Adverse Events (CTCAE Version 5.0)
Incidence of Serious Adverse Events
Whole Body Radiation Dose
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
OPTIMUM Trial Design
2Treatment groups
Experimental Treatment
Group I: 131I-MIBG + VorinostatExperimental Treatment1 Intervention
131I-MIBG + Vorinostat
Group II: 131I-MIBGExperimental Treatment1 Intervention
131I-MIBG
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
131I-MIBG
2005
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
Jubilant DraxImage Inc.Lead Sponsor
4 Previous Clinical Trials
15,858 Total Patients Enrolled
2 Trials studying Neuroblastoma
10 Patients Enrolled for Neuroblastoma
Melda DolanStudy DirectorJubilant DraxImage Inc., dba Jubilant Radiopharma
Norman LaFrance, MD,FACPStudy DirectorJubilant DraxImage Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My scans show that my cancer takes up a specific dye.I have had platelet transfusions but my current platelet count is above 50,000/μL without needing a transfusion for the last week.My thyroid function is normal, or if not, it's not a major concern.I have fully recovered from side effects of my previous treatments.I've had 131I-MIBG therapy over 6 months ago, without worsening cancer, as my only treatment.I have undergone total body irradiation.I have not taken valproic acid in the last 30 days.I am not taking any medications that affect my heart's rhythm and haven't taken Pentamidine in the last week.I am currently taking Coumadin.I have high-risk neuroblastoma that has come back or gotten worse despite treatment.I am at least 1 year old.My liver tests are within the required range.I have received less than 18 mCi/kg of 131I-MIBG in my lifetime.I have had a deep vein clot without having a central vein catheter.My scans show that all my cancer spots react to a specific diagnostic scan.I have previously undergone 131I-MIBG therapy.I have enough stored stem cells for the study.My kidney function, measured by GFR, is 70 mL/min/1.73 m2 or higher.I am currently on hemodialysis.I have significant heart, lung, or liver problems.I haven't had radiation in the last 2 weeks, or it's been 12 weeks if it was a large area.My biopsy showed a growing tumor is not neuroblastoma.I am a male and agree to use or have my partner use effective birth control during and 90 days after the study.I can do most activities by myself, regardless of my age.I had an allogeneic stem cell treatment over 4 months ago and have no active GVHD.I am not eligible for Vorinostat but can receive 131I-MIBG alone.My heart's pumping ability is confirmed to be normal recently.I had a stem cell transplant less than 12 weeks ago.I recently had immunotherapy or am still feeling its effects.I am not pregnant, can have children, and use effective birth control.I received 131I-MIBG therapy alone, not with other cancer drugs.I do not have active hepatitis B or C, or known HIV infection.
Research Study Groups:
This trial has the following groups:- Group 1: 131I-MIBG + Vorinostat
- Group 2: 131I-MIBG
Awards:
This trial has 1 awards, including:- 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.
Is enrollment currently open for this experiment?
"The records on clinicaltrials.gov demonstrate that this trial is actively enrolling patients. It was initially posted in October 2019 and the details were recently updated at the start of October 2022."
Answered by AI
How many sites are currently hosting this trial?
"Presently, 21 clinical trial sites are recruiting patients for this experiment. These locations span from New Hyde Park to Saint Louis and Charlotte in addition to 18 additional cities. To minimize travel needs if enrolled, it is beneficial to select the nearest site available."
Answered by AI
Has 131I-MIBG been investigated in other clinical research investigations?
"In 2005, 131I-MIBG was first tested at Lund University Hospital's Department of Pediatric Oncology and Bone Marrow Transplantation. Since then, 156 studies have been successfully completed while 36 are ongoing. The majority of these active trials take place in New Hyde Park, NY."
Answered by AI
How many participants have registered for the trial thus far?
"This research project requires 60 suitable candidates to join the study. Those eligible can enrol at Northwell Health/Cohen Children's Medical Center in New Hyde Park, NY or UPMC Children's Hospital of Pittsburgh in Saint Louis, Missouri."
Answered by AI
What potential risks should be considered when prescribing 131I-MIBG to patients?
"131I-MIBG was measured to be of moderate safety, as it scored a 2 on our team's scale. This radionuclide is currently in its second phase of assessment with some evidence surrounding safety but none related to efficacy."
Answered by AI
What medical conditions is 131I-MIBG typically used to treat?
"131I-MIBG is an effective solution for treating cutaneous t-cell lymphoma, as well as certain advanced directives, lvef ≤35%, and ctage1 protein, human."
Answered by AI
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