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NCT00499616 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma
A Phase 3 study of Neuroblastoma, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 464
- Enrollment target
- 20
- Study locations
NCT00499616: Completed Phase 3 study of Neuroblastoma, sponsored by Children's Oncology Group.
NCT00499616 is a Phase 3 study of Neuroblastoma that has completed, run by Children's Oncology Group. The registered enrollment target is 464 participants, above the 234-participant average among 94 other Neuroblastoma trials with a reported enrollment target (98% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00499616, a Phase 3 study of Neuroblastoma, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 464 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
OS time is calculated from date of enrollment until death, or until last contact if the patient is alive.
Conditions Studied
Interventions
- DRUG carboplatin
- DRUG cyclophosphamide
- DRUG etoposide
- DRUG doxorubicin hydrochloride
- DRUG topotecan hydrochloride
Study Locations (20)
California
- Southern California Permanente Medical Group - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Loma Linda University Cancer Institute at Loma Linda University Medical Center - Loma Linda
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital - Long Beach
- Childrens Hospital Los Angeles - Los Angeles
- Children's Hospital Central California - Madera
- Children's Hospital and Research Center Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital at Stanford University Medical Center - Palo Alto
- Sutter Cancer Center - Sacramento
- University of California Davis Cancer Center - Sacramento
- Kaiser Permanente Medical Center - Oakland - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
Alabama
- UAB Comprehensive Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Arizona
- Phoenix Children's Hospital - Phoenix
- Arizona Cancer Center at University of Arizona Health Sciences Center - Tucson
Arkansas
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences - Little Rock
Colorado
- Children's Hospital Center for Cancer and Blood Disorders - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 464 participants |
| Start Date | 2007-10-08 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 3 |
What the finished NCT00499616 record still lists
NCT00499616 is an interventional study that assigns participants to a tested intervention. The registered 464 participants enrollment target is mid-sized for trials with a published cap, above the 234-participant average among 94 other Neuroblastoma trials with a reported enrollment target (98% higher).
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 5 interventions - of which carboplatin is the first listed.
NCT00499616 names 20 study sites across 5 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00499616 about?
NCT00499616 is a clinical study titled "Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma". 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 ...
What is the current status of trial NCT00499616?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 464 participants. The study started on 2007-10-08. Estimated completion is 2021-06-30.
What conditions does trial NCT00499616 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT00499616?
The interventions under investigation include: carboplatin (DRUG), cyclophosphamide (DRUG), etoposide (DRUG), doxorubicin hydrochloride (DRUG), topotecan hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00499616?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00499616 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00499616's enrollment target sits among peer trials
464 11th of 94 higher than 84 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
RECRUITING · Phase 3
-
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
RECRUITING · Phase 3
-
Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma
ACTIVE NOT RECRUITING · Phase 3
-
A Web-Based Stem Cell Transplant Support System or Standard Care in Young Patients Undergoing Stem Cell Transplant and Their Families
COMPLETED · Phase 3
-
Surgery in Treating Children With Neuroblastoma
COMPLETED · Phase 3
-
MCT for the Harvard/UCSF ROBIN Center
RECRUITING · NA
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