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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
Must not have
History of total body irradiation.
Subjects do not have adequate renal function defined as GFR ≥ 70 mL/min/1.73 m2 either by creatinine clearance or radioisotope direct measurement or by calculation with the Schwartz formula.
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
No Placebo-Only Group

Summary

This trial tests a combination of a radioactive drug and a cancer-fighting pill in patients with a specific type of neuroblastoma that hasn't responded well to other treatments. The radioactive drug kills cancer cells, and the pill makes them more vulnerable to the drug.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have undergone total body irradiation.
Select...
My kidney function, measured by GFR, is 70 mL/min/1.73 m2 or higher.
Select...
I have had a deep vein clot without having a central vein catheter.
Select...
I am currently taking Coumadin.
Select...
I am currently on hemodialysis.
Select...
I have significant heart, lung, or liver problems.
Select...
I had an allogeneic stem cell treatment over 4 months ago and have no active GVHD.
Select...
I had a stem cell transplant less than 12 weeks ago.
Select...
I do not have active hepatitis B or C, or known HIV infection.

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).
This trial's timeline: 3 weeks for screening, Varies for treatment, and for all tumour assessment data collected throughout the study (up to the end of the 2-year follow-up)(131i-mibg + vorinostat). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response
Secondary study objectives
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 more
Other study objectives
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 • NCT02035137
92%
10035528-Platelet count decreased
86%
10002272-Anemia
84%
10029366-Neutrophil count decreased
81%
10049182-White blood cell decreased
76%
10025256-Lymphocyte count decreased
57%
10003481-Aspartate aminotransferase increased
54%
10047700-Vomiting
46%
10001551-Alanine aminotransferase increased
43%
10000636-Activated partial thromboplastin time prolonged
38%
10002646-Anorexia
35%
10021038-Hyponatremia
35%
10028813-Nausea
32%
10016256-Fatigue
30%
10020943-Hypoalbuminemia
30%
10011224-Cough
27%
10016558-Fever
27%
10020639-Hyperglycemia
27%
10021018-Hypokalemia
22%
10012727-Diarrhea
22%
10020949-Hypocalcemia
22%
10021059-Hypophosphatemia
19%
10010774-Constipation
19%
10020670-Hypermagnesemia
16%
10022402-INR increased
16%
10028735-Nasal congestion
14%
10047900-Weight loss
14%
10001675-Alkaline phosphatase increased
14%
10019211-Headache
14%
10040752-Sinus tachycardia
11%
10011368-Creatinine increased
11%
10006504-Bruising
11%
10021097-Hypotension
11%
10021028-Hypomagnesemia
11%
10033371-Pain
8%
10002855-Anxiety
8%
10020772-Hypertension
8%
10013781-Dry mouth
8%
10005364-Blood bilirubin increased
8%
10014383-Electrocardiogram QT corrected interval prolonged
8%
10003988-Back pain
5%
10000081-Abdominal pain
5%
10001760-Alopecia
5%
10020680-Hypernatremia
5%
10034310-Penile pain
5%
10014222-Edema face
5%
10033425-Pain in extremity
5%
10041367-Sore throat
5%
10001723-Allergic rhinitis
5%
10012174-Dehydration
5%
10025482-Malaise
5%
10000060-Abdominal distension
5%
10045158-Tumor pain
5%
10021005-Hypoglycemia
5%
10020647-Hyperkalemia
5%
10028130-Mucositis oral
5%
10021143-Hypoxia
5%
10056910-GGT increased
5%
10001497-Agitation
3%
10062501-Non-cardiac chest pain
3%
INFLUENZA A
3%
10016791-Flu like symptoms
3%
10009887-Colitis
3%
10016825-Flushing
3%
10017076-Fracture
3%
RESPIRATORY DEPRESSION FROM SEDATION
3%
10007810-Catheter related infection
3%
10008531-Chills
3%
10031009-Oral pain
3%
10041349-Somnolence
3%
10013573-Dizziness
3%
10046300-Upper respiratory infection
3%
10040047-Sepsis
3%
10065764-Mucosal infection
3%
10008496-Chest wall pain
3%
10033987-Paresthesia
3%
10037032-Proteinuria
3%
RIB PAIN
3%
10013911-Dysgeusia
3%
10038695-Respiratory failure
3%
MURMUR
3%
URETHRAL TRAUMA
3%
10035598-Pleural effusion
3%
10016059-Facial pain
3%
10046555-Urinary retention
3%
10054482-Neck edema
3%
10037868-Rash maculo-papular
3%
DRY CRACKED LIPS
3%
HYPERPHOSPHATEMIA
3%
10041232-Sneezing
3%
10065780-Muscle weakness left-sided
3%
10065776-Muscle weakness lower limb
3%
10049737-Treatment related secondary malignancy
3%
10017577-Gait disturbance
3%
10020587-Hypercalcemia
3%
10050068-Edema limbs
3%
10051792-Infusion related reaction
3%
ENTEROBACTER CLOCACAE
3%
10015090-Epistaxis
3%
10013963-Dyspnea
3%
JAW PAIN
3%
10021114-Hypothyroidism
3%
MULTIPLE BACTERIAL INFECTIONS (ENTEROBACTER, CITROBACTER, KLEBSIELLA, GPC, GVC)
3%
10025258-Lymphocyte count increased
3%
10019450-Hematuria
3%
10019245-Hearing impaired
3%
10028836-Neck pain
3%
10061322-Optic nerve disorder
3%
DISEASE PROGRESSION
3%
10030980-Oral hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
131I-MIBG With Vorinostat
Single-Agent 131I-MIBG
131I-MIBG With Vincristine/Irinotecan

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Norman LaFrance, MD,FACPStudy DirectorJubilant DraxImage Inc.
Melda DolanStudy DirectorJubilant DraxImage Inc., dba Jubilant Radiopharma
Marwan SamiaStudy DirectorJubilant DraxImage Inc., dba Jubilant Radiopharma

Media Library

131I-MIBG (Radioactive Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03561259 — Phase 2
Neuroblastoma Research Study Groups: 131I-MIBG + Vorinostat, 131I-MIBG
Neuroblastoma Clinical Trial 2023: 131I-MIBG Highlights & Side Effects. Trial Name: NCT03561259 — Phase 2
131I-MIBG (Radioactive Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03561259 — Phase 2
~10 spots leftby Dec 2025
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