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Expanded Access Protocol Using I131-MIBG

Expanded access is currently available for this treatment.
Verified September 2016 by Jubilant DraxImage Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01590680
First Posted: May 3, 2012
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jubilant DraxImage Inc.
May 1, 2012
May 3, 2012
September 27, 2016
 
Expanded Access Protocol Using I131-MIBG

Primary Objectives:

  • Provide palliative therapy with 131I-MIBG for patients with advanced neuroblastoma, pheochromocytoma, or paraganglioma.
  • Gain more information about acute and late toxicity of 131I-MIBG therapy for patients with refractory neuroblastoma, pheochromocytoma, or paraganglioma.
Neuroblastoma, pheochromocytoma, and paraganglioma remain fatal diseases for a large percentage of patients, especially those with high-risk disease features who become resistant to conventional therapy. 131I-metaiodobenzylguanidine (131I-MIBG) is a norepinephrine analog that concentrates in adrenergic tissue and has been shown to be sensitive and specific for detecting localized and metastatic neuroblastoma, pheochromocytoma, and paraganglioma. More importantly, experience of many institutions has proven that this agent used as a targeted radiotherapeutic has significant anti-tumor activity against refractory neuroblastoma 1-7 as well as pheochromocytoma and paraganglioma. Children's Hospital of Philadelphia, UCSF, and the University of Michigan have just completed a large Phase 2 study of 131I-MIBG given in doses of 10-18 mCi/kg with stem cell rescue, if necessary, and have shown that this agent is safe and effective palliative therapy for refractory or relapsed neuroblastoma patients. In addition, there is growing evidence that low-dose (5-10 mCi/kg) submyeloablative MIBG therapy is both safe and effective for disease palliation. This protocol therefore provides a mechanism to deliver this therapy when clinically indicated.
Expanded Access
Radiation: I-131 MIBG
The therapeutic dose (5-18 mCi/kg at investigator's discretion; any dose ≥12 mCi/kg requires stored stem cells) will be diluted in normal saline, and will be infused intravenously over 90-120 minutes.
Other Names:
  • I-131 Iobenguane
  • I-131 meta-iodobenzylguanidine
Not Provided
 
Available
Contact: Brian Weiss, M.D. 513-636-9863 brian.weiss@cchmc.org
Not Provided
 
 
NCT01590680
Jubilant DraxImage Inc.
Jubilant DraxImage Inc.
Not Provided
Principal Investigator: Weiss Brian, M.D. Cincinnati Children's Hospital (brian.weiss@cchmc.org)
Principal Investigator: Suzanne Shusterman, M.D. Dana-Farber Cancer Center Boston Children's Hospital (suzanne_shusterman@dfci.harvard.edu)
Principal Investigator: Greg Yanik, M.D. C.D. Mott's Children's Hospital University of Michigan, Ann Arbor (gyanik@umich.edu)
Principal Investigator: Howard Katzenstein, M.D. Monroe Caroll Children's Hospital at Vanderbilt (howard.katzenstein@vanderbilt.edu)
Principal Investigator: Michael Armstrong, M.D., Ph.D. Duke University Medical Center (michael.armstrong@duke.edu)
Principal Investigator: Julie Park, M.D. Seattle Children's Hospital (julie.park@seattlechildrens.org)
Principal Investigator: Meaghan Granger, M.D. Cook Children's Health Care System (maeghan.granger@cookchildrens.org)
Principal Investigator: Kenneth B. DeSantes, M.D. University of Wisconsin Comprehensive Cancer Center (kbdesantes@pediatrics.wisc.edu)
Principal Investigator: Kelly Goldsmith, M.D. Children's Healthcare of Atlanta (kgoldsmith@emory.edu)
Principal Investigator: Susan Cohn, M.D. University of Chicago (scohn@peds.bsd.uchicago.edu)
Principal Investigator: Margaret Macy, M.D. Children's Hospital Colorado (margaret.macy@childrenscolorado.org)
Principal Investigator: Tanya Watt, M.D. University of Texas Southwestern Medical Center (tanya.watt@utsouthwestern.edu)
Jubilant DraxImage Inc.
September 2016