CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 150 enrolled
Drug / intervention
Busulfan +14 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/NCT01798004
NCT01798004Phase 1Completed

Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients With Newly Diagnosed High-Risk Neuroblastoma

Children's Oncology Group·interventional·Posted Feb 25, 2013·Updated Jul 15, 2024

In Brief

A Phase 1 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Busulfan, and 13 other interventions for Ganglioneuroblastoma and 7 related conditions. Completed, enrolled 150 participants across 123 sites in 4 countries.

Detailed Summary

This pilot clinical trial studies busulfan, melphalan, and stem cell transplant after chemotherapy in treating patients with newly diagnosed neuroblastoma that is likely to come back or spread. Giving chemotherapy to the entire body before a stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is 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 chemotherapy.

Study Details

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

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 25, 2013
Enrollment StartApr 9, 2013
Primary CompletionJul 28, 2015
Study CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.4 years ago

Interventions

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous peripheral blood stem cell transplant

Busulfandrug

Given IV

Cisplatindrug

Given IV

Cyclophosphamidedrug

Given IV

Doxorubicin Hydrochloridedrug

Given IV

Etoposidedrug

Given IV

External Beam Radiation Therapyradiation

Undergo EBRT

Filgrastimbiological

Given SC or IV

Laboratory Biomarker Analysisother

Optional correlative studies

Melphalandrug

Given IV

Mesnadrug

Given IV

Peripheral Blood Stem Cell Transplantationprocedure

Undergo autologous peripheral blood stem cell transplant

Pharmacological Studyother

Correlative studies

Topotecan Hydrochloridedrug

Given IV

Vincristine Sulfatedrug

Given IV