131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 2

Conditions

Neuroblastoma

Treatments

Biological: filgrastim

Radiation: iobenguane I 131

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00293319

UCSF-05161

CDR0000454716

UCSF-00161

Details and patient eligibility

About

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.

Full 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.

Enrollment

164 patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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