- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01377532
Compassionate Use of 131I-MIBG for Patients With Malignant Pheochromocytoma
May 4, 2020 updated by: University of California, San Francisco
This is a compassionate use protocol to allow palliative therapy for patients with malignant pheochromocytoma and paragangliomas.
Study Overview
Status
Approved for marketing
Conditions
Intervention / Treatment
Detailed Description
Pheochromocytomas (PHEO) and paragangliomas (PGL) are rare tumors, with an incidence of 2-8 cases per million annually.
These tumors develop in both children and adults.
About 15-20% metastasize.
Chemotherapy for this tumor usually consists of a combination of cyclophosphamide, vincristine, and dacarbazine delivered over two days and repeated every 3 weeks.
Such combined chemotherapy is ineffective for the majority of patients with metastatic PHEO/PGL.
A few patients with malignant PHEO have experienced remissions with sunitinib, but the drug may produce severe toxicity and the experience with that drug is limited.
Those patients who do experience a remission with chemotherapy must continue it indefinitely to stay in remission.
However, most such patients experience such severe side effects from the chemotherapy (marrow suppression, neuropathy, etc) that their chemotherapy must be discontinued.
Thus, chemotherapy is either ineffective or intolerable for the vast majority of patients with metastatic PHEO/PGL.
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis: Refractory or relapsed PHEO/PGL with original diagnosis based on tumor histopathology or the finding of PHEO/PGL tumor cells in the bone marrow. The diagnosis may also be based upon the presence of high plasma fractionated metanephrines or high urine catecholamines/metanephrines with diagnostic MIBG uptake.
- Age: > 2 years and able to cooperate with radiation safety restrictions during therapy period.
- Disease status: It must be determined that either the PHEO/PGL tumors are not amenable to safe surgical resection or are metastatic. Disease evaluable by MIBG scan must be present within 6 weeks of study entry and subsequent to any intervening therapy.
- Life Expectancy: greater than 3 months.
- Lanksy and Karnofsky Performance Status: 70% or higher.
- Prior Therapy: Patients may enter this study with or without having had other therapy for recurrent tumor. Patients may be treated who have not had chemotherapy or radiation therapy. Patients may also be treated who have failed to respond to standard chemotherapy or radiation therapy. Patients must have fully recovered from the toxic effects of any prior therapy. At least 2 weeks should have elapsed since any anti-tumor therapy and the patient must meet hematologic criteria below. Three months should have elapsed in the case of completing radiation to any of the following fields: total craniospinal, total abdominal, whole lung, total body irradiation). Cytokine therapy (eg G-CSF, GM-CSF, IL-6, erythropoietin) must be discontinued a minimum of 24 hours prior to MIBG therapy. Prior 131I-MIBG therapy is allowed if > 8 weeks from previous treatment. Cumulative lifetime dose of 131I-MIBG, including the planned treatment, should not exceed 36 mCi/kg.
- Liver function: bilirubin < 2x upper limit of normal (ULN). Exception: Gilbert syndrome); AST < 10x ULN.
- Kidney function: Creatinine =< 2x ULN.
- Hematopoietic Criteria Patients must have adequate hematopoietic function (without transfusion): ANC >750 x 10E9/L; Platelets >50 x 10E9/L if stem cells are not available; if stem cells are available, the patient should be independent of platelet transfusions with a platelet count of at least 20 x 10E9/L. Hemoglobin >10g/dl at time of treatment (transfusion allowed). Patients with granulocytopenia and/or thrombocytopenia due to tumor metastatic to the bone marrow may be eligible after discussion with Dr. Fitzgerald or designee.
- Normal lung function as manifested by no dyspnea at rest or exercise intolerance, no oxygen requirement.
- No clinically significant cardiac dysfunction, normal EKG and EJ >50%
Exclusion Criteria:
- 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 or Vice Chair prior to patient entry.
- Patients with proteinuria in the absence of urinary infection 4 weeks prior to the planned treatment date.
- Because of the teratogenic potential of the study medications, no patients who are pregnant or breast feeding will be allowed. Patients of childbearing potential must practice an effective method of birth control while participating on this study, to avoid possible pregnancy.
- Patients who are on hemodialysis.
- Patients with active infections that meet grade 3-4 toxicity criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Paul Fitzgerald, MD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 13, 2011
First Submitted That Met QC Criteria
June 17, 2011
First Posted (ESTIMATE)
June 21, 2011
Study Record Updates
Last Update Posted (ACTUAL)
May 6, 2020
Last Update Submitted That Met QC Criteria
May 4, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Pheochromocytoma
- Paraganglioma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Radiopharmaceuticals
- 3-Iodobenzylguanidine
Other Study ID Numbers
- CompUse MIBG Pheo
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.
Clinical Trials on Pheochromocytoma
-
National Cancer Institute (NCI)RecruitingMetastatic Adrenal Gland Pheochromocytoma | Metastatic Paraganglioma | Unresectable Adrenal Gland Pheochromocytoma | Unresectable Paraganglioma | Advanced Adrenal Gland Pheochromocytoma | Advanced Paraganglioma | Stage III Adrenal Gland Pheochromocytoma and Sympathetic Paraganglioma AJCC v8 | Stage...United States
-
Peking Union Medical College HospitalRecruitingPheochromocytoma, Metastatic | Paraganglioma, Malignant | Pheochromocytoma MalignantChina
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Adrenal Gland Pheochromocytoma | Locally Advanced Paraganglioma | Metastatic Paraganglioma | Unresectable Adrenal Gland Pheochromocytoma | Unresectable Paraganglioma | Regional Adrenal Gland PheochromocytomaUnited States
-
Peking Union Medical College HospitalRecruitingUltrasonography | Pheochromocytoma, Metastatic | Paraganglioma, Malignant | Pheochromocytoma MalignantChina
-
Abramson Cancer Center of the University of PennsylvaniaCompletedUnresectable Paraganglioma | Recurrent Pheochromocytoma | Advanced Metastatic Paraganglioma | Advanced Metastatic Pheochromocytoma | Recurrent Paraganglioma | Unresectable PheochromocytomaUnited States
-
Peking Union Medical College HospitalCompletedPheochromocytoma, Metastatic | Paraganglioma, Malignant | Pheochromocytoma MalignantChina
-
Mayo ClinicNational Cancer Institute (NCI)CompletedMetastatic Adrenal Gland Pheochromocytoma | Malignant Adrenal Gland Pheochromocytoma | Malignant ParagangliomaUnited States
-
Peking Union Medical College HospitalRecruitingParaganglioma, Extra-Adrenal | Malignant Adrenal Gland Pheochromocytoma | Malignant Paraganglioma | Pheochromocytoma, Metastatic | Paraganglioma, MalignantChina
-
Kunwu Yan,MMCompletedHemodynamic | Adrenal Pheochromocytoma
-
National Cancer Institute (NCI)TerminatedParaganglioma | Metastatic Adrenal Gland Pheochromocytoma | Recurrent Adrenal Gland Pheochromocytoma | Extra-Adrenal ParagangliomaUnited States, Singapore, Hong Kong
Clinical Trials on 131 I-Metaiodobenzylguanidine (131 I-MIBG)
-
John MarisAvailableNeuroblastoma | Childhood Metastatic PheochromocytomaUnited States
-
Jubilant DraxImage Inc.AvailableNeuroblastoma | Pheochromocytoma | ParagangliomaUnited States
-
Jubilant DraxImage Inc.RecruitingNeoplasms | Neuroectodermal Tumors | NeuroblastomaUnited States
-
M.D. Anderson Cancer CenterCompletedMetastases, Neoplasm | Neuroendocrine TumorsUnited States
-
Nationwide Children's HospitalActive, not recruiting
-
Cellectar Biosciences, Inc.RecruitingMultiple Myeloma | Waldenstrom Macroglobulinemia | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Chronic Lymphocytic Leukemia | Lymphoplasmacytic Lymphoma | Diffuse Large B Cell Lymphoma | Small Lymphocytic Lymphoma | Central Nervous System LymphomaUnited States, Australia, Czechia, Greece, Israel, Brazil, Finland, France, Spain, Turkey, United Kingdom
-
Cellectar Biosciences, Inc.Active, not recruitingOsteosarcoma | Ewing Sarcoma | Neuroblastoma | Rhabdomyosarcoma | Pediatric Brain Tumor | DIPG | Pediatric Solid Tumor | Pediatric LymphomaUnited States, Australia, Canada
-
Molecular Insight Pharmaceuticals, Inc.CompletedPheochromocytoma | ParagangliomaUnited States
-
Cellectar Biosciences, Inc.National Cancer Institute (NCI)RecruitingHigh-Grade GliomaUnited States, Canada
-
David BushnellVA Office of Research and DevelopmentCompleted