131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma
This trial is active, not recruiting.
|Treatments||filgrastim, iobenguane i 131|
|Sponsor||University of California, San Francisco|
|Collaborator||National Cancer Institute (NCI)|
|Start date||April 2005|
|Trial size||50 participants|
|Trial identifier||NCT00293319, CDR0000454716, UCSF-00161, UCSF-05161|
RATIONALE: Radioactive drugs, such as 131 I-MIBG, may carry radiation directly to tumor cells and not harm normal cells.
PURPOSE: This phase II trial is studying how well 131 I-MIBG works in treating patients with refractory or relapsed neuroblastoma.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|San Francisco, CA||UCSF Comprehensive Cancer Center||no longer recruiting|
|Ann Arbor, MI||University of Michigan Comprehensive Cancer Center||no longer recruiting|
|Philadelphia, PA||Children's Hospital of Philadelphia||no longer recruiting|
Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy
Acute and late toxicities
Disease and symptom responses
Male or female participants at least 1 year old.
DISEASE CHARACTERISTICS: - Original diagnosis of neuroblastoma based on 1 of the following criteria: - Histopathology - Elevated urine catecholamines with typical tumor cells in the bone marrow - Refractory or relapsed disease, meeting 1 of the following criteria: - Failure to respond to standard therapy (e.g., combination chemotherapy with or without radiotherapy and surgery) - Evidence of disease progression (i.e., any new lesion or an increase in size of > 25% of a pre-existing lesion) at any time - Evaluable disease by MIBG scan within 6 weeks of study entry PATIENT CHARACTERISTICS: - Not pregnant or nursing - Fertile patients must use effective contraception - Negative pregnancy test - Bilirubin < 2 times normal - AST/ALT ≤ 10 times normal - Creatinine ≤ 2 mg/dL - Absolute neutrophil count* ≥ 750/mm^3 (transfusion independent) - Platelet count* ≥ 50,000/mm^3 (20,000/mm^3 if stem cells are available and platelet transfusion independent) - Hemoglobin* ≥ 10 g/dL (transfusion allowed) - No dyspnea at rest - No exercise intolerance - No oxygen requirement - No clinically significant cardiac dysfunction - No disease of any major organ system that would preclude study compliance - No active infection that meets grade 3 or 4 toxicity criteria NOTE: *Patients with granulocytopenia and/or thrombocytopenia due to tumor metastases to the bone marrow may be eligible at the discretion of the principal investigator PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Recovered from prior therapy - At least 2 weeks since prior antitumor therapy - At least 3 months since prior radiotherapy to any of the following fields: - Craniospinal - Total abdominal - Whole lung - Total body - At least 1 day since prior cytokine therapy (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], interleukin-6, or epoetin alfa) - Prior iodine I 131 metaiodobenzylguanidine allowed provided it was given more than 6 months ago AND patient has adequate hematopoietic stem cells available - No concurrent hemodialysis
|Official title||I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study|
|Description||OBJECTIVES: Primary - Determine if iodine I 131 metaiodobenzylguanidine can provide palliative therapy for patients with refractory or relapsed neuroblastoma. - Determine the acute and late toxicity of this regimen in these patients. Secondary - Determine disease and symptom responses of patients treated with this regimen. OUTLINE: This is a compassionate use study. Patients receive iodine I 131 metaiodobenzylguanidine IV over 2 hours. Beginning 10 days later, patients with low neutrophil counts receive filgrastim (G-CSF) subcutaneously until blood count recovers. Patients with stable or responding disease may receive a second dose of iodine I 131 metaiodobenzylguanidine at least 6 weeks after the first dose. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.|
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