Gene Modified Allogeneic Neuroblastoma Cells For Treatment of Relapsed/Refractory Neuroblastoma

Plain-language summary

This Phase 1 trial at St. Jude Children's Research Hospital explored using the immune system to eradicate advanced relapsed neuroblastoma, evaluating four to eight injections of interleukin-2 (IL-2) gene-transduced neuroblastoma cells. As described in the study summary, neuroblastoma affects about 500 children a year in the United States and responds well to therapy in infants, while in older children with disseminated tumor 80% or more can be expected to relapse within 3 years. Eligibility required a diagnosis of recurrent advanced stage neuroblastoma, a life expectancy of at least 8 weeks, recovery from the toxic effects of all prior chemotherapy, and an absolute neutrophil count above 500/mm3; the trial is completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

St. Jude Children's Research Hospital

Intervention

Interleukin-2 (Immunotherapy; gene transfer)

Start date

8/1/1998

Estimated completion

10/1/2007

Countries

United States

Related genes

Locations

• Memphis, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

* Diagnosis of recurrent advanced stage neuroblastoma.
* Must have a life expectancy of at least 8 weeks.
* Must have recovered from the toxic effects of all prior chemotherapy before entering this study, and have an absolute neutrophil count of \>500/mm3.
* Not be currently receiving any investigational agents or have not received any tumor vaccines within the previous six months.
* Bilirubin \<1.5 mg/dl.
* Creatinine \<1.5 mg/dl.
* ECOG performance status of 0-2 as below:
* Does not have rapidly progressive disease.
* Not pregnant or lactating.