Clinical trialNCT00499616CompletedPhase 3Interventional

Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma

SponsorChildren's Oncology GroupEnrollment464Neuroblastoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

RATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Isotretinoin may help neuroblastoma cells become more like normal cells, and grow and spread more slowly. Giving combination chemotherapy before surgery may make the tumor smaller and make it more likely that the tumor can be surgically removed. It is not yet known what is the minimal amount of chemotherapy needed to achieve sufficient tumor shrinkage to control intermediate risk neuroblastoma and prevent tumor recurrence or metastases. PURPOSE: This phase III trial is designed to reduce therapy for patients with favorable biology intermediate risk neuroblastoma by decreasing the number of chemotherapy cycles administered and by allowing for up to 50% residual tumor volume for patients with localized disease.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Clare Twist, MD
Lucile Packard Children's Hospital at Stanford University Medical Center
Study Chair
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Mary Lou Schmidt, MD
University of Illinois at Chicago
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

189 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

Children'S Hospital at Westmead
Westmead, New South Wales, Australia
Royal Children'S Hospital
Brisbane, Queensland, Australia
Women'S and Children'S Hospital
North Adelaide, South Australia, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia

Canada

Alberta Children'S Hospital
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Children'S & Women'S Hospital of British Columbia
Vancouver, British Columbia, Canada
Cancercare Manitoba
Winnipeg, Manitoba, Canada
Janeway Children'S Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada
Iwk Health Centre
Halifax, Nova Scotia, Canada
Mcmaster Children'S Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Children'S Hospital of Western Ontario
London, Ontario, Canada
Children'S Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Canada

Netherlands

Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, Netherlands

New Zealand

Starship Children'S Health
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand

Puerto Rico

San Jorge Children'S Hospital
Santurce, Puerto Rico

United States

Uab Comprehensive Cancer Center
Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Phoenix Children'S Hospital
Phoenix, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Jonathan Jaques Children'S Cancer Center at Miller Children'S Hospital
Long Beach, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Children'S Hospital Central California
Madera, California, United States
Children'S Hospital and Research Center Oakland
Oakland, California, United States
Children'S Hospital of Orange County
Orange, California, United States
Lucile Packard Children'S Hospital at Stanford University Medical Center
Palo Alto, California, United States
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States
Sutter Cancer Center
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States

149 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Filgrastim →Isotretinoin →Carboplatin →Cyclophosphamide →Doxorubicin →Etoposide →Topotecan →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 8 Oct 2007
Primary completion: 30 Jun 2014
Completion: 30 Jun 2021
Last update posted: 6 Jul 2021
Registered enrollment: 464
Registry id: NCT00499616

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.