Spots Global Cancer Trial Database for N2004-06: Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma
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Trial Identification
Brief Title: N2004-06: Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma
Official Title: Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma, A Phase I Study
Study ID: NCT00509353
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Childrens Hospital Los Angeles, Los Angeles, California, United States
Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia, United States
University of Chicago Comer Children's Hospital, Chicago, Illinois, United States
Children's Hospital Boston, Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
Contact Details
Name: Steven DuBois, MD
Affiliation: UCSF Medical Center at Parnassus
Role: PRINCIPAL_INVESTIGATOR
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