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A Phase I/II Study Of Immunization With Lymphotactin And Interleukin 2 Gene Modified Neuroblastoma Tumor Cells

NCT00703222 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-07-04

No results posted yet for this study

Summary

The investigators intend to test the safety, and immunologic and clinical efficacy of a combination of 2 allogeneic neuroblastoma tumor cell line vaccines, one of which has been genetically modified to secrete the cytokine/chemokine combination of IL-2 and lymphotactin, in patients undergoing chemotherapy for newly diagnosed, high risk neuroblastoma who receive single autologous stem cell rescue as consolidation therapy.

This protocol will be carried out as a Phase I/IIa study to evaluate the safety and toxicity of adding a previously unstudied, unmodified, irradiated neuroblastoma cell line (SKNLP) to a studied, safe dose of a gene modified, IL-2/Lptn secreting neuroblastoma cell line SJNB-JF-IL2/Lptn to be given as a vaccine to patients diagnosed with high risk neuroblastoma.

Conditions

Interventions

BIOLOGICAL

SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP

SJNB-JF-IL2 and SJNB-JF-Lptn at 1 x 10\^7 cells/m2 SKNLP at 1 x 10\^6 cells/m2

BIOLOGICAL

SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 2 SKNLP

SJNB-JF-IL2 and SJNB-JF-Lptn at 1 x 10\^7 cells/m2 SKNLP at 1 x 10\^7 cells/m2

Sponsors & Collaborators

  • Center for Cell and Gene Therapy, Baylor College of Medicine

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Andras A. Heczey, MD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-05-31
Completion
2025-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00703222 on ClinicalTrials.gov