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

NCT00186862 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2008-06-03

No results posted yet for this study

Summary

Neuroblastoma affects approximately 500 children a year in the United States. When the tumor occurs in infants, it is frequently localized and responds well to therapy. Even disseminated disease can be eradicated in about 75% of infants, and indeed may undergo spontaneous remission. In older children, the prognosis is far worse, and 80% or more of those with disseminated tumor can be expected to relapse within 3 years.

This study will utilize the concept of exploiting the immune system to eradicate neuroblastoma. In tumors in which there is consistent expression of tumor specific antigens as part of the malignant process, it may be possible to generate immune T-cells ex-vivo or in-vivo by using the specific protein or peptide(s) derived therefrom and eradicate the tumor. This study will evaluate the use of four to eight injections of IL-2 gene-transduced autologous neuroblastoma cells to induce a local, polyclonal T-cell infiltrate as well as an anti-tumor immune response.

Conditions

Interventions

DRUG

Interleukin-2

A genetically modified (retroviral) allogeneic tumor vaccine coupled with the human interleukin-2. Patients were treated with 4 injections of these gene-modified tumor cells. The first two were given at weeks 1 and 2. Patients then had a 2 week rest and the remaining 2 injections were given at weeks 4 and 5. A complete evaluation for evidence of toxicity and response were performed at week 8. At this week 8 evaluation, if there was no excessive toxicity, progressive disease requiring therapy, and if more transduced cells are available, patients had the option to receive 4 additional injections. These additional injections were separated by 1 month at the higher of the two dosage levels originally received.

Sponsors & Collaborators

Principal Investigators

  • Gregory A Hale, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-08-31
Primary Completion
2000-04-30
Completion
2007-10-31

Countries

  • United States

Study Locations

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Diseases
Companies

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 NCT00186862 on ClinicalTrials.gov