N2004-06: Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma
- Conditions
- Neuroblastoma
- Interventions
- Registration Number
- NCT00509353
- Lead Sponsor
- Children's Hospital Los Angeles
- Brief Summary
RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIGB), may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as irinotecan and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving iodine I 131 MIGB together with irinotecan and vincristine may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of iodine I 131 MIGB when given together with irinotecan and vincristine in treating young patients with resistant or relapsed high-risk neuroblastoma.
- Detailed Description
OBJECTIVES:
Primary
* To determine the maximum tolerated dose (MTD) of iodine I 131 metaiodobenzylguanidine when given in combination with fixed-dose irinotecan hydrochloride and vincristine in young patients with refractory or relapsed high-risk neuroblastoma.
* To determine the dose-limiting toxicities of iodine I 131 metaiodobenzylguanidine when combined with fixed-dose irinotecan hydrochloride and vincristine.
Secondary
* To determine if there is a therapeutic response to this regimen.
OUTLINE: This is a multicenter, dose-escalation study of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG).
Patients receive \^131I-MIBG IV over 1½-2 hours on day 1, vincristine IV on days 0 and 7, and irinotecan hydrochloride IV over 1 hour on days 0-4 and 7-11. Treatment repeats every 56 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Group irinotecan hydrochloride - Single Group vincristine sulfate - Single Group iobenguane I 131 -
- Primary Outcome Measures
Name Time Method To determine the maximum tolerated dose (MTD) of 131I-MIBG given in combination with fixed-dose irinotecan/vincristine to children with high-risk refractory/relapsed neuroblastoma. Tolerability will be assessed throughout the study. To determine the dose limiting toxicities of 131I-MIBG combined with irinotecan/vincristine. Adverse events, clinically significant changes in laboratory results, and vital signs, to be measured throughout the study.
- Secondary Outcome Measures
Name Time Method Within the confines of a Phase I study, to determine if there is a therapeutic response to this regimen. Disease response will be evaluated at baseline, prior to each cycle and at the end of treatment. Disease response will be evaluated by any of the following CT, MRI, MIBG, Bone Marrow, Urine Catecholamines at baseline, prior to each cycle and at the end of treatment.
Trial Locations
- Locations (12)
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
University of Chicago Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
🇺🇸Atlanta, Georgia, United States
Lucile Packard Children's Hospital at Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States