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Phase I Study of Cytokine-Gene Modified Autologous or Partially Matched Allogeneic Neuroblastoma Cells for Treatment of Relapsed/Refractory Neuroblastoma

Phase 1
21 Years
Not Enrolling

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Trial Information

Phase I Study of Cytokine-Gene Modified Autologous or Partially Matched Allogeneic Neuroblastoma Cells for Treatment of Relapsed/Refractory Neuroblastoma

OBJECTIVES: I. Determine the safety in children of recurrent neuroblastoma of two weekly
subcutaneous injections of autologous, or partially HLA-matched allogeneic, neuroblastoma
cells that have been modified by insertion of the interleukin-2 gene introduced by a
retroviral vector. II. Determine whether multiple histocompatibility-restricted or
unrestricted antitumor immune responses are induced by this treatment and the cell dose
required to produce these effects. III. Obtain preliminary data on the antitumor effects of
this regimen.

OUTLINE: Autologous or partially HLA-matched allogeneic neuroblastoma cells are transduced
with a human gene for interleukin-2 production. Patients receive subcutaneous injections of
the gene-modified cells on days 1 and 8, with the second injection containing 10 times more
cells than the first injection. After a 3-4 week rest, stable and responding patients may
receive additional weekly injections at the second dose. Cohorts of 3-6 patients will be
entered at increasing cell doses until the maximum tolerated dose is estimated. Multiple
injection sites may be used at the higher cell-dose levels. Patients are followed every week
for 6 weeks, every other week for 6 weeks, and monthly for 1 year. Additional visits may be
required as clinically indicated.

PROJECTED ACCRUAL: Approximately 12 patients each will be entered into the autologous and
the partially HLA-matched allogeneic tumor cell treatment groups. Accrual is expected to
require 4 years for the autologous tumor cell group and 2 years for the partially
HLA-matched allogenic tumor cell group.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven high risk neuroblastoma at the completion
of planned primary therapy No rapidly progressing disease Allogeneic transduced cell line
available Demonstrated production of at least 150 picograms of interleukin-2 per 10 to the
6th cells per day

PATIENT CHARACTERISTICS: Age: Under 21 at diagnosis Performance status: ECOG 0-2 Life
expectancy: At least 8 weeks Hematopoietic: (unless marrow replaced by tumor) Absolute
neutrophil count greater than 500/mm3 Platelet count greater than 50,000/mm3 Hepatic:
Bilirubin less than 1.5 mg/dL AST no greater than 2 times normal PT normal Renal:
Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 80 mL/min Urinalysis
normal Metabolic: Electrolytes (including calcium, phosphate) normal Glucose normal Weight
greater than 10th percentile for age Albumin greater than 3 g/dL Other: No active
infection HIV negative Not pregnant or nursing

PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from prior chemotherapy No
concurrent antibiotics except prophylactic trimethoprim/sulfamethoxazole No concurrent
drugs other than analgesics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Gregory Hale, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Jude Children's Research Hospital


United States: Federal Government

Study ID:




Start Date:

December 1991

Completion Date:

August 2007

Related Keywords:

  • Neuroblastoma
  • recurrent neuroblastoma
  • Neuroblastoma



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