MIBG Therapy for Cancer
(MIBG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a Phase II study for patients with MIBG avid tumors. The study is to determine the response rate to \<131\>I-MIBG in patients with de novo, relapsed or refractory neuroblastoma or other MIBG avid malignant tumors 42 days post MIBG therapy. It will also be evaluating the tolerability and safety of the study agent by evaluating the hematopoietic and non-hematopoietic toxicity of \<131\>I-MIBG therapy. Tumor response will be evaluated by comparing the patient's disease pre-treatment against the patient's day +42 post \<131\>I-MIBG treatment. The evaluations may include the following: \<131\>I-MIBG scan, CT or MRI, urine catecholamine, bone marrow analyses and any other tests considered standard of care for cancer evaluation. To be eligible for participation, patients must have tumors that are MIBG avid. Patients must also have a stem cell source for autologous rescue in the event of protracted therapy associated cytopenias. Peripheral stem cell collections are preferred as the hematopoietic cell source. Bone marrow harvests for a hematopoietic cell source is an alternative. This study will provide data for future clinical trials utilizing \<131\>I-MIBG therapies. A room on H12 has been prepared with lead lined walls, and many radiation safety components to accomodate this treatment. \<131\>I metaiodobenzlguanidine (\<131\>I-MIBG) is a radiopharmaceutical that concentrates within adrenomedullary tissue. The agent was initially used for tumor imaging due to its capability to locate pheochromocytomas, neuroblastomas and other neuroendocrine tumors. \<131\>I-MIBG was subsequently used as an therapeutic agent for these tumor types. Phase I and II therapeutic trials targeting neuroblastoma have reported response rates of 10-50%. Toxicities observed have been mainly hematopoietic, with \~50% of patients receiving 15mCi/kg requiring stem cell reinfusion. Observed non-hematopoietic toxicities have been mild. Most recently, trials have been conducted combining the study agent with myeloablative chemotherapy and stem cell reinfusion have been performed with initial response rates of \~50%.
Who Is on the Research Team?
Mark Ranalli
Principal Investigator
Nationwide Children's Hospital
Are You a Good Fit for This Trial?
This trial is for people aged 1 to 65 with MIBG avid tumors, such as neuroblastoma. They should have recovered from previous treatments and not be pregnant or breastfeeding. Participants need a stem cell source ready for rescue in case of severe blood cell count drops due to treatment. Major organ function must be stable, and they can't have had certain prior radiation therapies or an active infection needing IV drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive <131>I-MIBG therapy for MIBG avid tumors
Follow-up
Participants are monitored for safety and effectiveness after treatment, with evaluations at 42 days post therapy
Extension
Participants may continue to be monitored for long-term safety and effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- <131>I-MIBG
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nationwide Children's Hospital
Lead Sponsor