Status:

COMPLETED

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

Lead Sponsor:

St. Jude Children's Research Hospital

Collaborating Sponsors:

Texas Children's Cancer Center

National Cancer Institute (NCI)

Conditions:

Neuroblastoma

Eligibility:

All Genders

Up to 21 years

Phase:

PHASE1

Brief 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 b...

Detailed Description

Secondary objectives for this protocol included the following: * To determine whether major histocompatibility complex (MHC) restricted or unrestricted antitumor immune responses are induced by injec...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    August 1 1998

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2007

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT00186862

    Start Date

    August 1 1998

    End Date

    October 1 2007

    Last Update

    June 3 2008

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    St. Jude Children's Research Hospital

    Memphis, Tennessee, United States, 38105