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NCT00107289 | RECRUITING | Neuroblastoma

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

Condition or disease

Neuroblastoma

Pheochromocytoma

Intervention/treatment

iobenguane I 131

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors
Actual Study Start Date : 2006-05
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2026-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 1 Year
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 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.
  • 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.
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma

Location Details

NCT00107289

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How to Participate

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Locations

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065