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

This study has been completed.
Sponsor:
Collaborators:
Texas Children's Cancer Center
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00186862
First received: September 12, 2005
Last updated: June 2, 2008
Last verified: June 2008
  Purpose

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 be eradicated in about 75% of infants, and indeed may undergo spontaneous remission. In older children, the prognosis is far worse, and 80% or more of those with disseminated tumor can be expected to relapse within 3 years.

This study will utilize the concept of exploiting the immune system to eradicate neuroblastoma. In tumors in which there is consistent expression of tumor specific antigens as part of the malignant process, it may be possible to generate immune T-cells ex-vivo or in-vivo by using the specific protein or peptide(s) derived therefrom and eradicate the tumor. This study will evaluate the use of four to eight injections of IL-2 gene-transduced autologous neuroblastoma cells to induce a local, polyclonal T-cell infiltrate as well as an anti-tumor immune response.


Condition Intervention Phase
Neuroblastoma
Drug: Interleukin-2
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Chemokine and Cytokine Gene Modified Allogeneic Neuroblastoma Cells For Treatment of Relapsed/Refractory Neuroblastoma Using a Retroviral Vector

Resource links provided by NLM:


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

Primary Outcome Measures:
  • • 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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: August 1998
Study Completion Date: October 2007
Primary Completion Date: April 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Interleukin-2

A genetically modified (retroviral) allogeneic tumor vaccine coupled with the human interleukin-2. Patients were treated with 4 injections of these gene-modified tumor cells. The first two were given at weeks 1 and 2. Patients then had a 2 week rest and the remaining 2 injections were given at weeks 4 and 5. A complete evaluation for evidence of toxicity and response were performed at week 8.

At this week 8 evaluation, if there was no excessive toxicity, progressive disease requiring therapy, and if more transduced cells are available, patients had the option to receive 4 additional injections. These additional injections were separated by 1 month at the higher of the two dosage levels originally received.

Other Name: Immunotherapy; gene transfer

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 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.
  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186862

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Texas Children's Cancer Center
Investigators
Principal Investigator: Gregory A Hale, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Gregory Hale, MD, St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00186862     History of Changes
Other Study ID Numbers: CYCHAL
Study First Received: September 12, 2005
Last Updated: June 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
Neuroblastoma
Immunotherapy
Gene therapy

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 April 16, 2014