CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 665 enrolled
Drug / intervention
Carboplatin +15 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00567567
NCT00567567Phase 3Completed

Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma

Children's Oncology Group·interventional·Posted Dec 5, 2007·Updated Apr 28, 2022

In Brief

A Phase 3 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Carboplatin, and 14 other interventions for Localized Resectable Neuroblastoma and 5 related conditions. Completed, enrolled 665 participants across 190 sites in 6 countries.

Detailed Summary

This randomized phase III trial compares two different high-dose chemotherapy regimens followed by a stem cell transplant in treating younger patients with high-risk neuroblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments before a peripheral blood stem cell transplant helps kill any tumor cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. High-dose chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the high- chemotherapy. It is not yet known which regimen of high-dose chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, New Zealand, Puerto Rico, Switzerland, United States

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 5, 2007
Enrollment StartNov 5, 2007
Primary CompletionFeb 27, 2015
Study CompletionMar 31, 2022
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 18.6 years ago

Interventions

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous peripheral blood stem cell transplant

Carboplatindrug

Given IV

Cisplatindrug

Given IV

Cyclophosphamidedrug

Given IV

Doxorubicin Hydrochloridedrug

Given IV

Etoposidedrug

Given IV

External Beam Radiation Therapyradiation

Undergo EBRT

Filgrastimbiological

Given IV or SC

Isotretinoindrug

Given orally

Laboratory Biomarker Analysisother

Correlative studies

Melphalandrug

Given IV

Peripheral Blood Stem Cell Transplantationprocedure

Undergo autologous peripheral blood stem cell transplant

Pharmacological Studyother

Correlative studies

Thiotepadrug

Given IV

Topotecan Hydrochloridedrug

Given IV

Vincristine Sulfate Liposomedrug

Given IV