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Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory High-Risk NBL.

NCT00874315 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-10-16

No results posted yet for this study

Summary

RATIONALE: - Relapsed or refractory Neuroblastoma (NBL) carries a very poor prognosis and children with relapsed NBL have an overall 3 year survival rate of \< 10%. Hematopoietic Stem Cell Transplant from a different donor (allogeneic), is a form of adoptive cellular therapy , such that infused donor cells find host tumors as foreign and fight them. After transplant, the donor immune cells (i.e. T cells, NK cells) mediate Graft versus Tumor (GVT) effect and may stop tumor from recurring. Also,reduced intensity transplants lead to minimal toxicity and less risk of mortality in heavily pre-treated NBL patients.

PURPOSE: This phase II trial is studying how well giving a reduced intensity(using Fludarabine, Busulfan and antithymocyte globulin)preparative regimen followed by donor stem cell transplant works in treating young patients with high-risk neuroblastoma that has relapsed or not responded to treatment.

Conditions

Interventions

OTHER

anti-thymocyte globulin

2.5 mg/kg/day for 4 doses on day -3, -2 , -1 and day +2.

DRUG

busulfan

0.8 mg/kg/dose for total of 8 doses.

DRUG

cyclosporine

1.5 mg/kg/dose every 12 hours.

DRUG

fludarabine phosphate

30 mg/m2/day for 5 days.

DRUG

mycophenolate mofetil

15 mg/kg/dose every 8 hours

DRUG

tacrolimus

0.03 mg/kg/day as continuous infusion or 12 hour divided doses

PROCEDURE

allogeneic hematopoietic stem cell transplantation

Donor stem cell transplantation from HLA matched sibling donor or an unrelated donor.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Sandeep Soni, MD · Nationwide Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00874315 on ClinicalTrials.gov