Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||N/A and Over|
- - Diagnosis: - Relapsed/refractory neuroblastoma with original diagnosis based on tumor histopathology or elevated urine catecholamines with typical neuroblastoma cells in the bone marrow - Metastatic pheochromocytoma - Age >1 year and able to cooperate with radiation safety restrictions during therapy period - Karnofsky or Lansky performance status of ≥ 50% - Life expectancy: patients must have a life expectancy of at least 8 weeks - Disease status: Failure to respond to standard therapy (usually combination chemotherapy with or without radiation and surgery) or development of progressive disease at any phase of standard therapy (any new lesion or an increase in size >25% of a pre-existing lesion).
- - Disease must be evaluable by MIBG scan.
- - Stem Cells: If a patient does not have a hematopoietic stem cell product available for re-infusion after MIBG treatment, they may not receive a 131IMIBG dose >12 mCi/kg.
- - Stem cell source: The patients on this protocol will have autologous PBSCs available.
- - Have acceptable organ function as defined below within 7 days of enrollment: - Bone Marrow: ANC ≥750 X 109 /L, platelets ≥50,000 X 109 /L, and hemoglobin ≥ 8.0 g/dL without transfusion if stem cells are not available.
- - Renal: Creatinine ≤ 2 times upper limit of normal - Hepatic: Bilirubin ≤2x upper limit of normal; AST/ALT ≤10x upper limit of normal - Cardiac: Ejection fraction ≥ 45% on echocardiogram or shortening fraction >/=27% - Pulmonary: normal lung function as manifested by no dyspnea and/or oxygen saturation ≥ 94% on room air.
- - Prior Therapy: Patients must have recovered from all acute toxicities (defined as CTCAE 5.0 ≤ grade 1) associated with any prior therapy, and: - Myelosuppressive chemotherapy: At least 2 weeks should have elapsed since any chemotherapy causing myelosuppression - Biologic (anti-neoplastic agent): At least 7 days should have elapsed since the completion of therapy with a biologic agent.
- - Monoclonal antibodies: At least 3 half-lives should have elapsed since therapy with a monoclonal antibody - Radiation therapy: Three-months should have elapsed in the case of completing radiation to any of the following fields: craniospinal, total abdominal, whole lung, total body irradiation).
- - Cytokine therapy (e.g. G-CSF, GM-CSF, IL-6, IL-2): must be discontinued a minimum of 24 hours prior to MIBG therapy.
- - Voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- - Patients with disease of any major organ system that would compromise their ability to withstand therapy.
- - Because of the teratogenic potential of the study medication, no patients who are pregnant or lactating will be allowed.
- - Known allergy to any of the agents or their ingredients used in this study.
- - Patients who are on hemodialysis - Patients with untreated positive blood cultures or progressive infections as assessed by radiographic studies - Patients who have had prior treatment with 131I-MIBG who do not meet the re-treatment criteria.
- - In patients with metastatic pheochromocytoma, screening urinalysis required prior to study enrollment.
- - Patients with known MIBG-avid parenchymal brain metastases are excluded.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Early Phase 1|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Texas Southwestern Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Tanya Watt, MD|
|Principal Investigator Affiliation||University of Texas Southwestern Medical Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Relapsed Neuroblastoma, Metastatic Pheochromocytoma|
Primary Objective is to provide access to therapy with 131I-MIBG for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma. Secondary Objectives are to
- (1) assess disease response to 131I-MIBG therapy for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma; (2) gain more information about the toxicities of 131I-MIBG therapy; and (3) assess improvement of symptoms, including pain and fatigue, for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma who are receiving 131I-MIBG therapy.
Experimental: 131 I-MIBG Treatment Arm
Therapeutic 131 I-Metaiodobenzylguanidine (131I-MIBG) will be infused intravenously, intravenous fluids will be administered to help maintain urine flow and isotope excretion. Potassium iodide solution will be administered to protect thyroid function. G-CSF will be used if necessary for neutrophil recovery. Hematopoietic stem cell infusion if meets the criteria.
Drug: - 131 I-Metaiodobenzylguanidine
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.
Drug: - Potassium Iodide
For the therapeutic MIBG administration, potassium iodide solution will be administered in a loading dose of 6mg/kg orally at least 8 hours prior to the MIBG injection, and then will be given at 1mg/kg/dose every 4 hours on days 0-6, then 1 mg/kg/day through day 45 post injection.
Drug: - G-csf
It is recommended that patients with ANC less than 750 after MIBG infusion begin G-CSF 5 mcg/kg/day subcutaneously (or receive equivalent single dose of Neulasta every 14 days while neutropenic) until neutrophil recovery (generally >5000). This will start 24 hours after stem cell infusion (if stem cells are to be infused).
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.