Clinical Trials /

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

NCT00107289

Description:

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.

Related Conditions:
  • Adrenal Gland Pheochromocytoma
  • Neuroblastoma
  • Paraganglioma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
  • Official Title: Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors

Clinical Trial IDs

  • ORG STUDY ID: 04-148
  • SECONDARY ID: MSKCC-04148
  • NCT ID: NCT00107289

Conditions

  • Neuroblastoma
  • Pheochromocytoma

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
RadiationExperimental

    Eligibility Criteria

            Inclusion criteria for NB:
    
              -  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 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.
    
            Inclusion criteria for malignant CCT:
    
              -  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.
    
            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.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:1 Year
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Response (complete or partial)
    Time Frame:2 years
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Correlation between tumor self-absorbed dose and response and tumor volume decrease
    Time Frame:2 years
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Memorial Sloan Kettering Cancer Center

    Trial Keywords

    • metastatic pheochromocytoma
    • recurrent pheochromocytoma
    • regional pheochromocytoma
    • recurrent neuroblastoma
    • 04-148

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