Iobenguane (131-I) + Vorinostat for Neuroblastoma
(OPTIMUM Trial)
Recruiting in Palo Alto (17 mi)
+20 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Jubilant DraxImage Inc.
Must not be taking: Valproic acid, QT prolonging drugs
Disqualifiers: Pregnancy, Breastfeeding, HIV, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot take valproic acid within 30 days of starting the study, and you should not be on medications that prolong the QT interval when you begin the trial.
What data supports the effectiveness of the drug combination Iobenguane (131-I) and Vorinostat for treating neuroblastoma?
Research shows that 131I-MIBG is effective in treating neuroblastoma, especially in relapsed cases, with response rates ranging from 0% to 75%. Vorinostat, when combined with 131I-MIBG, may enhance the treatment's effectiveness due to its properties that make cancer cells more sensitive to radiation.
12345Is the combination of Iobenguane (131-I) and Vorinostat safe for treating neuroblastoma?
Research shows that Iobenguane (131-I) is generally safe for treating neuroblastoma, even in high-risk cases, and Vorinostat is being studied for its potential to enhance this treatment. However, the combination's safety is still being evaluated, and more studies are needed to fully understand the risks.
12456What makes the drug combination of Iobenguane (131-I) and Vorinostat unique for treating neuroblastoma?
This drug combination is unique because it uses Iobenguane (131-I), a radiopharmaceutical that targets neuroblastoma cells, together with Vorinostat, which enhances the effect of radiation by making cancer cells more sensitive to it. This approach aims to improve the effectiveness of treatment for relapsed or hard-to-treat neuroblastoma.
14578Eligibility Criteria
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.Inclusion 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.
+24 more
Exclusion Criteria
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.
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Up to 4 weeks
Treatment
Participants receive 131I-MIBG as a single agent or in combination with Vorinostat. The treatment phase lasts up to 26 weeks for two treatments or 16 weeks for one treatment.
16-26 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments for disease progression and adverse events.
2 years
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: 131I-MIBG + VorinostatExperimental Treatment1 Intervention
131I-MIBG + Vorinostat
Group II: 131I-MIBGExperimental Treatment1 Intervention
131I-MIBG
131I-MIBG is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Azedra for:
- Pheochromocytoma
- Neuroblastoma
🇪🇺 Approved in European Union as Iobenguane I-131 for:
- Neuroblastoma
- Pheochromocytoma
- Paraganglioma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Nemours Children's Specialty CareJacksonville, FL
University of Chicago Medical CenterChicago, IL
Cook Children's Hematology/Oncology CenterFort Worth, TX
Stanford UniversityPalo Alto, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Jubilant DraxImage Inc.Lead Sponsor
References
Upfront consolidation treatment with 131I-mIbG followed by myeloablative chemotherapy and hematopoietic stem cell transplantation in high-risk neuroblastoma. [2022]Label="IMPORTANCE" NlmCategory="OBJECTIVE"> 131I-metaiodobenzylguanidine (131I-mIBG) has a significant targeted antitumor effect for neuroblastoma. However, currently there is a paucity of data for the use of 131I-mIBG as a "front-line" therapeutic agent in those patients with newly diagnosed high-risk neuroblastoma as part of the conditioning regimen for myeloablative chemotherapy (MAC).
Feasibility, toxicity and response of upfront metaiodobenzylguanidine therapy therapy followed by German Pediatric Oncology Group Neuroblastoma 2004 protocol in newly diagnosed stage 4 neuroblastoma patients. [2017]Label="AIM OF THE STUDY">Radiolabelled meta-iodobenzylguanidine (MIBG) is an effective option in treatment of neuroblastoma (NBL) tumours. We studied feasibility, toxicity and efficacy of upfront 131I-MIBG and induction treatment in stage 4 NBL patients.
A systematic review of 131I-meta iodobenzylguanidine molecular radiotherapy for neuroblastoma. [2022]The optimal use and effectiveness of (131)I-meta iodobenzylguanidine ((131)I-mIBG) molecular radiotherapy for neuroblastoma remain unclear despite extensive clinical experience. This systematic review aimed to improve understanding of the current data and define uncertainties for future clinical trials. Bibliographic databases were searched for neuroblastoma and (131)I-mIBG. Clinical trials and non-comparative case series of (131)I-mIBG therapy for neuroblastoma were included. Two reviewers assessed papers for inclusion using the title and abstract with consensus achieved by discussion. Data were extracted by one reviewer and checked by a second. Studies with multiple publications were reported as a single study. The searches yielded 1216 citations, of which 51 publications reporting 30 studies met our inclusion criteria. No randomised controlled trials (RCTs) were identified. In two studies (131)I-mIBG had been used as induction therapy and in one study it had been used as consolidation therapy. Twenty-seven studies for relapsed and refractory disease were identified. Publication dates ranged from 1987 to 2012. Total number of patients was 1121 with study sizes ranging from 10 to 164. There was a large amount of heterogeneity between the studies with regard to patient population, treatment schedule and response assessment. Study quality was highly variable. The objective tumour response rate reported in 25 studies ranged from 0% to 75%, mean 32%. We conclude that (131)I-mIBG is an active treatment for neuroblastoma, but its place in the management of neuroblastoma remains unclear. Prospective randomised trials are essential to strengthen the evidence base.
A safety and feasibility trial of 131 I-MIBG in newly diagnosed high-risk neuroblastoma: A Children's Oncology Group study. [2022]Label="INTRODUCTION"> 131 I-meta-iodobenzylguanidine (131 I-MIBG) is effective in relapsed neuroblastoma. The Children's Oncology Group (COG) conducted a pilot study (NCT01175356) to assess tolerability and feasibility of induction chemotherapy followed by 131 I- MIBG therapy and myeloablative busulfan/melphalan (Bu/Mel) in patients with newly diagnosed high-risk neuroblastoma.
Phase I Study of Vorinostat as a Radiation Sensitizer with 131I-Metaiodobenzylguanidine (131I-MIBG) for Patients with Relapsed or Refractory Neuroblastoma. [2018](131)I-metaiodobenzylguanidine (MIBG) is a radiopharmaceutical with activity in neuroblastoma. Vorinostat is a histone deacetylase inhibitor that has radiosensitizing properties. The goal of this phase I study was to determine the MTDs of vorinostat and MIBG in combination.
Safety and efficacy of tandem 131I-metaiodobenzylguanidine infusions in relapsed/refractory neuroblastoma. [2013]Targeted radiotherapy with (131) I-Metaiodobenzylguanidine ((131) I-MIBG) is safe and effective therapy for patients with relapsed neuroblastoma, but anti-tumor activity is sometimes transient. The goal of this study was to determine the safety and efficacy of early (
Feasibility of dosimetry-based high-dose 131I-meta-iodobenzylguanidine with topotecan as a radiosensitizer in children with metastatic neuroblastoma. [2013](131)I-meta iodobenzylguanidine ((131)I-mIBG) therapy is established palliation for relapsed neuroblastoma. The topoisomerase-1 inhibitor, topotecan, has direct activity against neuroblastoma and acts as a radiation sensitiser. These 2 treatments are synergistic in laboratory studies. Theoretically, the benefit of (131)I-mIBG treatment could be enhanced by dose escalation and combination with topotecan. Haematological support would be necessary to overcome the myelosuppression, which is the dose-limiting toxicity.
Upfront treatment of high-risk neuroblastoma with a combination of 131I-MIBG and topotecan. [2015](131)I-metaiodobenzylguanidine ((131) I-MIBG) has a significant anti-tumor effect against neuroblastoma (NBL). Topotecan (TPT) can act as a radio-sensitizer and can up-regulate (131) I-MIBG uptake in vitro in NBL.