Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors

Who is this study for? Patients with Neuroblastoma
What treatments are being studied? Iobenguane I 131
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this research study is to find how active and safe 131 I-MIBG is in patients with resistant neuroblastoma, malignant pheochromocytoma and malignant paraganglioma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: f
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• Patients must have the diagnosis of NB in accordance with the International Criteria, i.e., either histopathology (confirmed by the MSKCC Department of Pathology) or BM involvement plus elevated urinary catecholamines.

• Must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy.

• Patients must have MIBG-avid NB and evaluable disease on MIBG scan at time of enrollment on protocol

• Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy.

• Age \>1 year with a determination that radiation safety restrictions during therapy period can be implemented.

• Stem cells: Patients for high does must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. Patients for low dose do not require cryopreserved autologous hematopoietic stem cell product available. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells/kg.

• Minimum life expectancy of eight weeks

• Signed informed consent indicating awareness of the investigational nature of this program.

• Patients must have the diagnosis of malignant CCT i.e. malignant pheochromocytoma or malignant paraganglioma

• Patients must have MIBG-avid malignant CCT and evaluable disease on MIBG scan at time of enrollment on protocol

• Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy.

• Age between 1 and 21 years and able to cooperate with radiation safety restrictions during therapy period

• Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells/kg.

• Minimum life expectancy of eight weeks.

• Signed informed consent indicating awareness of the investigational nature of this program.

Locations
United States
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Contact Information
Primary
Ellen Basu, MD, PhD
212-639-5204
Backup
Shakeel Modak, MD
212-639-7623
Time Frame
Start Date: 2006-05
Estimated Completion Date: 2026-05
Participants
Target number of participants: 200
Treatments
Experimental: Radiation
Sponsors
Leads: Memorial Sloan Kettering Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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