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An Open Label, Expanded Access Protocol Using 131I-metaiodobenzylguanidine (131I-MIBG)Therapy in Patients With Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma

Status
Active
Cancer Type
Adrenal Cancer
Neuroblastoma
Trial Phase
Eligibility
12 months and over, Male and Female
Study Type
Treatment
NCT ID
NCT01590680
Protocol IDs
JDI2007-01 (primary)
NCI-2014-01104
Study Sponsor
DRAXIMAGE

Summary

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.

Objectives

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.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston


1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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