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Autologous Transplant Followed by Allogeneic Transplant for High Risk Neuroblastoma

NCT00670410 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-06-24

No results posted yet for this study

Summary

Neuroblastoma is a malignant tumor of the sympathetic nervous system. It is the second most common malignant tumor of childhood. Although modest advances have been made over the past 20 years children with high-risk neuroblastoma continue to have an unsatisfactory long-term survival. This study will administer induction chemotherapy followed by high-dose (myeloablative) chemotherapy with autologous stem cell transplantation, followed by radiation therapy, then immunotherapy with a non myeloablative allogeneic stem cell transplant for treatment of neuroblastoma. The purpose of this clinical research trial is to study the feasibility of giving immunotherapy with a non-myeloablative allogeneic transplant (NAT/AlloSCT), following myeloablative therapy and autologous stem cell transplant (MAT/AutoSCT). This study will also determine the side effects as well as the response rate for each group of patients (treatment arm).

Conditions

Interventions

PROCEDURE

Related donor transplant

Patients with a related donor will get reduced intensity transplant conditioning with busulfan and fludarabine.

PROCEDURE

Cord blood transplant

Patients with a matched cord blood donor will get reduced intensity conditioning with busulfan, fludarabine, and ATG.

DRUG

Busulfan

Busulfan (Busulfex) \[4mg/kg/dose for patients \< 4 years; 3.2 mg/kg/dose for patients \> 4 years\] will be given IV in 0.9% sodium chloride or D5W to a final concentration \> 0.5 mg/mL solution for infusion equal to 10 times the volume of diluent to Busulfex, through a central venous access device over 3 hours once daily.

DRUG

Thymoglobulin

Patients with an umbilical cord blood donor will also receive Thymoglobulin (ATG-rabbit) during the preparative regimen.

DRUG

Fludarabine

Fludarabine 30 mg/m2 x 5 days, total dose = 150 mg/m2. Patients \< 12 kg will receive Fludarabine 1 mg/kg x 5 days, total dose = 5 mg/kg. Fludarabine will be given IV in 100 ml (or to a concentration of 1 mg/mL) of D5W or 0.9% sodium chloride, and infused over 30 min on Days -6 to 2.

Sponsors & Collaborators

Principal Investigators

  • Darrell Yamashiro, MD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00670410 on ClinicalTrials.gov