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MIBG Therapy for Patients With MIBG Avid Tumors (MIBG)

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ClinicalTrials.gov Identifier: NCT02378428
Recruitment Status : Recruiting
First Posted : March 4, 2015
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Ranalli, Nationwide Children's Hospital

Brief 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 agent with myeloablative chemotherapy and stem cell reinfusion have been performed with initial response rates of ~50%.

Condition or disease Intervention/treatment Phase
MIBG Avid Tumors Drug: MIBG Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of <131>I-Metaiodobenzyguanidine (<131>I-MIBG) Therapy for Patients With MIBG Avid Tumors
Study Start Date : March 2014
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MIBG
Research participants with MIBG avid tumors
Drug: MIBG
Other Name: <131>I-Metaiodobenzylguanidine




Primary Outcome Measures :
  1. To determine the response rate to <131>I-MIBG treatment. [ Time Frame: Response rate will be assessed at 42 days post therapy. ]
    Responses will be defined by comparison to baseline studies obtained prior to study therapy. Disease status will be evaluated using CT/MRI scans, MIBG scans, plain films, as well as bone marrow aspiration and biopsy as dictated by the primary malignant diagnosis. Imaging modalities should be the same for pre and post MIBG assessments to facilitate response determination.



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Ages Eligible for Study:   12 Months to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Diagnosis: diagnosis of neuroblastoma or at the time of relapse by histology and/or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites

Disease Status:

  • The presence of refractory or progressive disease (PD)
  • The presence of mixed response (MR), or no response (NR) following the completion of A3973 or equivalent induction therapy, or the presence of a partial response (PR) with high Curie score (>2) following induction therapy.
  • Patients with de novo high risk neuroblastoma who have completed standard induction therapy and do not achieve a CR, VGPR, or PR with low Curie score post induction.
  • Patients must have evidence of MIBG avid disease as determined by diagnostic MIBG scan obtained within 4 weeks of study entry.
  • Performance Level and Life Expectancy: Patients must have a Lansky Play Scale17 of 60% (<16 yrs old), Karnofsky score 60% (>16 yrs old), or ECOG score of < or equal to 2 and a life expectancy of 2 months.

Exclusion Criteria:

  • Pregnancy or breast feeding
  • Have undergone a prior allogeneic BMT.
  • Patients with disease of any major organ system that would compromise their ability to withstand therapy. Any significant organ impairment should be discussed with the Study Chair prior to patient entry.
  • Patients who are on hemodialysis.
  • Hepatitis B surface antigen (+) or Hepatitis C positive in preceding six months.
  • Patients with an active infection requiring intravenous antivirals, antibiotics or antifungals. Patients on prolonged antifungal therapy are still eligible if they are culture negative and biopsy negative in suspected residual radiographic lesions have stabilized or regressed and they meet other organ function criteria.
  • Prior total body irradiation, prior total abdominal or whole liver radiation
  • Any medical or psychological condition or situation deemed by the PI to put the patient at increased risk of complications or noncompliance.
  • Patients with curative treatment options.
  • Patients for whom busulfan/ melphalan consolidation therapy following treatment with 131I-MIBG is planned.
  • Patients for who CEM (carboplatin, etoposide, melphalan) therapy is administered within 30 days prior to 131I-MIBG therapy or for whom this therapy is planned within 30 days following administration of 131I-MIBG.
  • Patients with known MIBG avid brain metastasis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378428


Contacts
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Contact: Melinda Triplet, RN 614-722-6039 melinda.triplet@nationwidechildrens.org
Contact: Amy Yekisa 614-722-6570 amy.yekisa@nationwidechildrens.org

Locations
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United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Principal Investigator: Mark A Ranalli, MD         
Sponsors and Collaborators
Mark Ranalli
Investigators
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Principal Investigator: Mark A Ranalli, MD Nationwide Children's Hospital

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Responsible Party: Mark Ranalli, Princpal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02378428     History of Changes
Other Study ID Numbers: IRB13-00656
NCH MIBG ( Other Identifier: Columbus CRI )
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Keywords provided by Mark Ranalli, Nationwide Children's Hospital:
Neuroblastoma
Additional relevant MeSH terms:
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3-Iodobenzylguanidine
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals