Neuroblastoma
Conditions
Keywords
recurrent neuroblastoma
Brief summary
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.
Detailed 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.
Interventions
BIOLOGICALfilgrastim
RADIATIONiobenguane I 131
Sponsors
National Cancer Institute (NCI)
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy | — |
| Acute and late toxicities | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease and symptom responses | — |
Countries
United States
Outcome results
None listed