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Gene Therapy in Treating Children With Refractory or Recurrent Neuroblastoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: St. Jude Children's Research Hospital
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002748
  Purpose

RATIONALE: Inserting the gene for interleukin-2 into a person's neuroblastoma cells may make the body build an immune response and kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of using interleukin-2 gene-modified neuroblastoma cells in treating children who have refractory or recurrent neuroblastoma.


Condition Intervention Phase
Neuroblastoma
Drug: interleukin-2 gene
Procedure: gene-modified tumor cell vaccine therapy
Phase I

MedlinePlus related topics: Cancer Neuroblastoma
Drug Information available for: Interleukin-2
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: PHASE I STUDY OF CYTOKINE-GENE MODIFIED AUTOLOGOUS OR PARTIALLY MATCHED ALLOGENEIC NEUROBLASTOMA CELLS FOR TREATMENT OF RELAPSED/REFRACTORY NEUROBLASTOMA

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 12
Study Start Date: December 1991
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002748

Locations
United States, Tennessee
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Study Chair: Gregory Hale, MD St. Jude Children's Research Hospital
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000064681, SJCRH-CYGENE, SJCRH-CYGNE2, NCI-H96-0005
Study First Received: November 1, 1999
Last Updated: December 24, 2008
ClinicalTrials.gov Identifier: NCT00002748  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent neuroblastoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Interleukin-2
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Neuroectodermal Tumors, Primitive, Peripheral
Recurrence
Neuroblastoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Pharmacologic Actions
Neoplasms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Neoplasms, Neuroepithelial
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009