This trial is active, not recruiting.

Condition neuroblastoma
Treatments filgrastim, iobenguane i 131
Phase phase 2
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

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy
time frame:
Acute and late toxicities
time frame:

Secondary Outcomes

Disease and symptom responses
time frame:

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).