Gene Therapy in Treating Children With Refractory or Recurrent Neuroblastoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00002748
First received: November 1, 1999
Last updated: October 3, 2011
Last verified: October 2011
  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
Biological: gene-modified tumor cell vaccine therapy
Biological: interleukin-2 gene
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of Cytokine-Gene Modified Autologous or Partially Matched Allogeneic Neuroblastoma Cells for Treatment of Relapsed/Refractory Neuroblastoma

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Enrollment: 38
Study Start Date: December 1991
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Tennessee
St. 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002748     History of Changes
Other Study ID Numbers: CDR0000064681, U01CA058211, P30CA021765, SJCRH-CYGENE, SJCRH-CYGNE2, NCI-H96-0005
Study First Received: November 1, 1999
Last Updated: October 3, 2011
Health Authority: United States: Federal Government

Keywords provided by St. Jude Children's Research Hospital:
recurrent neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014