N2000-01: Double Infusion of Iodine I 131 Metaiodobenzylguanidine Followed by Autologous Stem Cell Transplantation
- Conditions
- Neuroblastoma
- Registration Number
- NCT00083135
- Lead Sponsor
- Children's Hospital Los Angeles
- Brief Summary
RATIONALE: Giving iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) may kill neuroblastoma cells by delivering radiation directly to the tumor. A stem cell transplant using the patient's stem cells may be able to replace blood-forming cells destroyed by radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of a double infusion of \^131I-MIBG followed by autologous stem cell transplantation in treating patients with refractory neuroblastoma.
- Detailed Description
OBJECTIVES:
Primary
* Determine the maximum tolerated red marrow radiation dose delivered and associated toxic effects of escalating activity of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) followed by autologous hematopoietic stem cell transplantation in patients with refractory neuroblastoma.
* Determine the number of days after stem cell transplantation to achieve absolute neutrophil count ≥ 500/mm\^3 for 3 days and platelet count ≥ 20,000/mm\^3 for 3 days (without transfusions) in patients treated with this regimen.
Secondary
* Determine the response rate in patients treated with this regimen, based on lesions measurable by CT or MRI at study entry, patients with \^131I-MIBG scan-positive lesions only, and patients with minimal residual tumor in bone marrow who have complete response by immunocytology and morphology.
* Determine the tumor absorbed radiation dose in patients with measurable soft tissue lesions treated with this regimen.
* Correlate, if possible, TP53 mutations with response in patients with accessible bone marrow tumor treated with \^131I-MIBG.
OUTLINE: This is a dose-escalation, multicenter study.
* Iodine I 131 metaiodobenzylguanidine (131I-MIBG) therapy: Patients receive\^131I-MIBG IV over 2 hours on days 0 and 14.
Cohorts of 3-6 patients receive escalating doses of \^131I-MIBG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
* Stem cell transplantation therapy: Patients undergo autologous peripheral blood stem cell transplantation on day 28. Patients receive filgrastim (G-CSF) IV over 1 hour OR subcutaneously daily beginning on day 28 and continuing until blood counts recover.
Patients are followed every 3 months for 1 year and then annually thereafter.
PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States