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Phase I Study of Chemokine and Cytokine Gene Modified Allogeneic Neuroblastoma Cells For Treatment of Relapsed/Refractory Neuroblastoma Using a Retroviral Vector


Phase 1
N/A
21 Years
Not Enrolling
Both
Neuroblastoma

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Trial Information

Phase I Study of Chemokine and Cytokine Gene Modified Allogeneic Neuroblastoma Cells For Treatment of Relapsed/Refractory Neuroblastoma Using a Retroviral Vector


Secondary objectives for this protocol included the following:

- To determine whether major histocompatibility complex (MHC) restricted or unrestricted
antitumor immune responses are induced by injection of modified allogeneic neuroblasts
and the cell doses required to produce these effects.

- To obtain preliminary data on the antitumor effects of this treatment regimen.

Inclusion Criteria


- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

• To determine the safety of up to eight subcutaneous injections of allogeneic neuroblastoma cells that have been genetically modified by retroviral vectors to secrete lymphotactin and Interleukin-2

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Gregory A Hale, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

CYCHAL

NCT ID:

NCT00186862

Start Date:

August 1998

Completion Date:

October 2007

Related Keywords:

  • Neuroblastoma
  • Neuroblastoma
  • Immunotherapy
  • Gene therapy
  • Neuroblastoma

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794