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NCT02378428 · ClinicalTrials.gov registry record · Phase 2
MIBG Therapy for Patients With MIBG Avid Tumors
A Phase 2 study of MIBG Avid Tumors, sponsored by Nationwide Children's Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT02378428 is a Phase 2 study of MIBG Avid Tumors that is active but no longer recruiting, run by Nationwide Children's Hospital. The registered enrollment target is 65 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02378428, a Phase 2 study of MIBG Avid Tumors, is active but no longer recruiting, sponsored by Nationwide Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Conditions Studied
Interventions
- DRUG MIBG
Study Locations (1)
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2014-03-01 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02378428
The ClinicalTrials.gov registry entry for NCT02378428 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with MIBG Avid Tumors appearing as the primary indexed condition, and to 1 intervention - of which MIBG is the first listed.
NCT02378428 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT02378428 about?
NCT02378428 is a clinical study titled "MIBG Therapy for Patients With MIBG Avid Tumors". 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 safe...
What is the current status of trial NCT02378428?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2014-03-01. Estimated completion is 2025-12-31.
What conditions does trial NCT02378428 study?
This clinical trial studies the following conditions: MIBG Avid Tumors.
What interventions are being tested in trial NCT02378428?
The interventions under investigation include: MIBG (DRUG).
Who is sponsoring clinical trial NCT02378428?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02378428 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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