MIBG for Refractory Neuroblastoma and Pheochromocytoma
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- STATUS
- Recruiting
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- End date
- Dec 23, 2022
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- participants needed
- 100
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- sponsor
- Masonic Cancer Center, University of Minnesota
Summary
This is a best available therapy/compassionate use single institution study designed to determine the palliative benefit and toxicity of 131I-MIBG in patients with progressive neuroblastoma and metastatic pheochromocytoma who are not eligible for therapies of higher priority. Patients may receive a range of doses depending on stem cell availability and tumor involvement of bone marrow. Response rate, toxicity, and time to progression and death will be evaluated.
Description
Primary Objective is to provide access to therapy with 131I-MIBG for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma.
Secondary Objective is to assess disease response to 131I-MIBG therapy for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma.
Tertiary Objectives are to 1) gain more information about the toxicities of 131I-MIBG therapy; 2) assess improvement of symptoms, including pain and fatigue, for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma who are receiving 131I-MIBG therapy.
- The therapeutic dose of 131I-MIBG will be based on the following:
- Minimum dose of 10 mCi/kg for patients without a stem cell source whose renal function is above the upper limit of normal but still meets eligibility criteria.
- Dose of 12 mCi/kg for patients without a stem cell source with normal renal function and meets other eligibility criteria.
- Dose of > 12 mCi/kg to 18 mCi/kg maximum at investigator's discretion for patients meeting eligibility criteria with stem cells available.
- A urinary catheter and intravenous fluids will be used for bladder protection, and potassium iodide solution for thyroid Protection.
- G-CSF is recommended for patients with ANC less than 750 after MIBG infusion.
- hematopoietic stem cell infusion is recommended for patients with grade 4 hematologic toxicity following 131I-MIBG therapy that continues to have an ANC <200 on G-CSF without signs of recovery for >2 weeks and any patient requiring platelet transfusion more than two times weekly for 4 consecutive weeks.
- Follow-up will be done until disease progression, death or other therapies are initiated.
Details
| Condition | Relapsed Neuroblastoma, Metastatic Pheochromocytoma |
|---|---|
| Treatment | G-CSF, 131 I-Metaiodobenzylguanidine (131I-MIBG), Potassium iodide solution, hematopoietic stem cell infusion |
| Clinical Study Identifier | NCT01850888 |
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Last Modified on | 23 March 2022 |
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