- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02378428
MIBG Therapy for Patients With MIBG Avid Tumors (MIBG)
A Phase II Study of <131>I-Metaiodobenzyguanidine (<131>I-MIBG) Therapy for Patients With MIBG Avid Tumors
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Amy Yekisa
- Phone Number: 614-722-6570
- Email: Amy.Yekisa@nationwidechildrens.org
Study Locations
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Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients must be between 12 months and 65 years at the time of enrollment
- 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)
- For patients with neuroblastoma, 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.
- Patients who receive greater than 12 mCi/kg are required to have stem cell rescue products harvested prior to study treatment.
- 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.
- Patients may enter this study with or without salvage therapy for recurrent tumor. Patients must have fully recovered from the toxic effects of any prior therapy.
- Organ Function requirements:
Hematopoietic Criteria:
- Hemoglobin- 10 gl/dl (transfusion allowed)
- ANC- 550 / cu mm (off myeloid growth factors)
- Platelets- > 50,000/cu mm. (transfusion allowed - however patients must not require more than two platelet transfusions per week).
Renal Function:
a. Serum Creatinine- < 2 x ULN for age.
Hepatic Function:
Total bilirubin <1.5 x ULN for age SGPT (ALT) and SGOT (AST) < 10 x ULN for age
Cardiac Function:
For children with NBL: Normal ejection fraction (>55%) documented by echocardiogram or radionuclide MUGA evaluation OR normal fractional shortening (>27%) documented by echocardiogram.
For subjects with paraganglioma/ pheochromocytoma: No clinically significant cardiac dysfunction.
Pulmonary Function:
Patients must have clinically normal lung function as manifested by no dyspnea at rest and no oxygen requirement
Reproductive Function:
- Females of childbearing potential must have a negative pregnancy test within 1 week prior to treatment with 131I-MIBG.
- Patients of childbearing potential must agree to use an effective birth control method.
- Female patients who are lactating must agree to stop breast feeding
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: MIBG
Research participants with MIBG avid tumors
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the response rate to <131>I-MIBG treatment.
Time Frame: Response rate will be assessed at 42 days post therapy.
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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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Response rate will be assessed at 42 days post therapy.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark A Ranalli, MD, Nationwide Children's Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB13-00656
- NCH MIBG (Other Identifier: Columbus CRI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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AmgenCompletedCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced MalignancyUnited States, Australia
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NantCell, Inc.CompletedQUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid TumorsCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced Malignancy
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AmgenCompletedSolid Tumors | Oncology | Tumors
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University of California, San FranciscoMerck Sharp & Dohme LLCCompletedCancer | Advanced Solid Tumors | TumorsUnited States
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Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
Clinical Trials on MIBG
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GE HealthcareCompletedCongestive Heart FailureUnited States
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Miguel PampaloniMolecular Insight Pharmaceuticals, Inc.; Jubilant DraxImage Inc.Terminated
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Mayo ClinicEnrolling by invitationDementia | Mild Cognitive Impairment | Lewy Body Disease | Parkinsonism | REM Sleep Behavior DisorderUnited States
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Kieuhoa VoCannonball Kids Cancer Foundation, IncAvailableNeuroblastomaUnited States
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University of California, San FranciscoCompletedPheochromocytoma | ParagangliomaUnited States
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Tomsk National Research Medical Center of the Russian...CompletedChronic Heart FailureRussian Federation
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National Center for Research Resources (NCRR)UnknownNeuroblastomaUnited States
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University of California, San FranciscoThrasher Research FundCompleted
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AC Camargo Cancer CenterWithdrawnNeuroendocrine TumorsBrazil
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Jubilant DraxImage Inc.RecruitingNeoplasms | Neuroectodermal Tumors | NeuroblastomaUnited States