Spots Global Cancer Trial Database for Expanded Access Protocol Using 131I-MIBG
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Trial Identification
Brief Title: Expanded Access Protocol Using 131I-MIBG
Official Title: An Open Label, Expanded Access Protocol Using 131I-metaiodobenzylguanidine (131I-MIBG) Therapy in Patients With Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma (Not Eligible for Approved Treatment)
Study ID: NCT01590680
Interventions
Study Description
Brief Summary: Protocol JDI2007-01 is an Expanded Access Protocol with therapeutic 131I-MIBG for patients with neuroblastoma or pheochromocytoma / paraganglioma, who otherwise do not qualify for available treatments, or where approved treatment is not commercially available.
Detailed Description: Primary Objectives: * To provide 131I-MIBG for compassionate use in patients with neuroblastoma, who otherwise do not qualify for inclusion or cannot participate in the sponsor's pivotal Phase II, FDA-approved, clinical trial. * To provide 131I-MIBG for compassionate use in patients with neuroblastoma in the absence of a commercially available FDA approved product for the indication. * Provide palliative therapy with 131I-MIBG for patients with advanced neuroblastoma. * To provide alternative therapeutic 131I-MIBG options for patients with pheochromocytoma / paraganglioma, not qualifying for FDA-approved MIBG treatment. * To provide alternative therapeutic 131I-MIBG options for patients with pheochromocytoma / paraganglioma, in the absence of a commercially available FDA-approved product for that indication. * Gain more information about acute and late toxicity of 131I-MIBG therapy for patients with refractory neuroblastoma, pheochromocytoma, or paraganglioma. Patients will receive a therapeutic dose at the investigator's discretion (5-18 mCi/kg). However, a dose of 12 mCi/kg or higher requires stored stem cells. Patients may be eligible for additional 131I-MIBG treatments (up to a cumulative total of 3 treatments) if they meet certain criteria. Treatments with 131I-MIBG must be separated by a minimum of six weeks from previous 131I-MIBG therapy. Post-treatment evaluation will be performed 5-9 weeks (35-63 days) post treatment, and patients will be followed every 6 months until 2 years from therapy. All patients will have toxicity monitoring for 2 years following 131I-MIBG therapy, or until going off study.
Keywords
Eligibility
Minimum Age: 12 Months
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Michigan Medicine, University of Michigan, Ann Arbor, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
North Carolina Children's Hospital, Chapel Hill, North Carolina, United States
Carolinas Medical Center/ Levine Children's Hospital, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Cincinnati Children's Hospital, Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, Tennessee, United States
Children's Medical Center Dallas, Dallas, Texas, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Baylor College of Medicine, Texas Children's Hospital, Houston, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
University of Wisconsin Hospital and Clinics, American Family Children's Hospital, Madison, Wisconsin, United States
Contact Details
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