Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma

Phase 2

Recruiting

• Conditions: Neuroblastoma; Pheochromocytoma
• Interventions: Drug: iobenguane I 131

• Registration Number: NCT00107289
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2005-04-05
• Study First Submitted QC: 2005-04-05
• Study First Posted: 2005-04-06
• Study Start: 2006-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-12
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

• Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 2 or less. A grade 3 hearing deficit is acceptable.
• Active serious infections not controlled by antibiotics.
• Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.
• Inability or unwillingness to comply with radiation safety procedures or protocol requirements.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation	iobenguane I 131	-

Primary Outcome Measures

Name	Time	Method
Response (complete or partial)	2 years

Secondary Outcome Measures

Name	Time	Method
Correlation between tumor self-absorbed dose and response and tumor volume decrease	2 years

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States