N2004-06: Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
New Approaches to Neuroblastoma Therapy Consortium
Study ID
NCT00509353
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 31, 2007
Status verified
Nov 2023
Primary completion
Oct 31, 2010
Completion
May 31, 2012

Study Design

Enrollment
26 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Group

Primary Outcome Measure

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. [ Time Frame: Tolerability will be assessed throughout the study. ]

Locations (12)

FacilityCityStateZIPSite coordinators
Childrens Hospital Los AngelesLos AngelesCalifornia90027-0700-
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo AltoCalifornia94304-
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94115-
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston CampusAtlantaGeorgia30322-
University of Chicago Comer Children's HospitalChicagoIllinois60637-
Children's Hospital BostonBostonMassachusetts02115-
C.S. Mott Children's Hospital at University of Michigan Medical CenterAnn ArborMichigan48109-0286-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-3039-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-4318-
Cook Children's Medical Center - Fort WorthFort WorthTexas76104-
Children's Hospital and Regional Medical Center - SeattleSeattleWashington98105-
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadisonWisconsin53792-6164-

Find similar trials in Los Angeles, CA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Childrens Hospital Los Angeles· Los Angeles, CALucile Packard Children's Hospital at Stanford University Medical Center· Palo Alto, CAUCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAAFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus· Atlanta, GAUniversity of Chicago Comer Children's Hospital· Chicago, ILChildren's Hospital Boston· Boston, MA

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