Targeted radiotherapy for chemotherapy resistant neuroblastoma with I-131 metaiodobenzylguanidine (MIBG)
- Conditions
- euroblastomaNeuroblastoma, I-131 MIBG therapy
- Registration Number
- JPRN-jRCTs041180041
- Lead Sponsor
- Kinuya Seigo
- Brief Summary
Sixty-three neuroblastoma patients received I-131 MIBG treatment (23 cases of newly diagnosed and 46 cases of recurrent neuroblastoma). In the study period, there were 20 deaths due to exacerbation of the disease and 6 deaths from continuous treatment complications. The 5-year estimated survival rate after the initial treatment of I-131 MIBG was 65% in the newly diagnosed patients and 45% in the recurrent patient. The safe administration of I-131 MIBG for neuroblastoma was possible.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 63
1)Patients with histologically proven neuroblastoma
2)Positive I-131 MIBG uptake
3)Age > 1 y.o.
4)Patients with written informed consent from parents
5)Patients with ADL adequate for treatment in an isolation room. Patients with limited ADL that can be compensated by the others under the approval of the ethical board.
6)In case that high-dose treatment is chosen, bone marrow support must be secured.
1)Patients with disturbed consciousness
2)An expected life expectancy of less than 1 month
3)Limited bone marrow capacity (except patients with bone marrow support)
hemoglobin<9.0g/dl, white blood cell count<3,000, platelet count<10,000
4)Renal disorder
glomerular filtrated rate (GFR)<30ml/min/1.73m2
5)Risks for the central nerve compression syndrome that might be caused by lesion edema during the treatment
6)In case that medical practice and radiation management is difficult in an isolation room, In case of uncontrolled symptoms that require emergent medical cares, In case that urine management is difficult, In case that understanding and cooperation cannot be obtained from family members
7)When medical staffs determine that treatment cannot be properly carried out.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Assessment of anti-tumor effects with tumor size and tumor markers<br>2)Assessment of prognosis<br>3)Assessment of symptoms
- Secondary Outcome Measures
Name Time Method Incidence and type of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE v 3.0)<br>1)Bone marrow: hemoglobin, total white blood cell, neutrophils/granulocytes, platelets<br>2)Gastrointestinal (radiation sickness) : appetite loss, nausea, vomiting<br>3)Salivary gland disorder<br>4)Thyroid disorder<br>5)Neurological disorder<br>6)Endocrine disorder: induction of catecholamine excess symptoms