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

NCT00703222 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 22053-CHESAT
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Neuroblastoma

Keywords

high-risk neuroblastoma; single autologous stem cell rescue

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety of repeated immunization with gene-modified, IL-2/lymphotactin secreting SJNB-JF-IL2 and SJNB-JF-Lptn cells co-administered with the unmodified SKNLP neuroblastoma cell line.

  21-day window following the first vaccination will constitute the time period for DLT assessment. Dose limiting toxicity will be any grade 3 or 4 non-hematologic toxicity as per the CTCAE v3.0 or a grade 3 injection site toxicity per the CTCAE 3.0. Toxicities after the initial as well as after subsequent vaccinations will be summarized separately.

  1 year

Secondary Outcomes (1)

• Evaluate the immune response to these immunizations.

  1 year

Study Arms (2)

Dose Level 1

EXPERIMENTAL

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

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

Dose Level 2

EXPERIMENTAL

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

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

Interventions

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

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

Dose Level 1

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

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

Dose Level 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \<21 years at time of diagnosis
• Histological proof of high-risk neuroblastoma at diagnosis
• Anticipating single autologous stem cell rescue following high dose consolidation chemotherapy
• Meet all eligibility criteria for high dose chemotherapy with stem cell rescue per institutional standard
• Signed informed consent
• Patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
• HIV negative

You may not qualify if:

• Patients must not be currently receiving any investigational agents or have received any tumor vaccines within the previous six months
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant
• HIV-positive patients regardless of treatment status

Sponsors & Collaborators

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

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Andras A. Heczey, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Dose escalation

Study Record Dates

• First Submitted: June 20, 2008
• First Posted: June 23, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)