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NCT00703222 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study Of Immunization With Lymphotactin And Interleukin 2 Gene Modified Neuroblastoma Tumor Cells
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT00703222 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 7 participants.
The verdict
NCT00703222, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
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.
Interventions
- BIOLOGICAL SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP
- BIOLOGICAL SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 2 SKNLP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2008-06 |
| Est. Completion | 2025-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00703222
The ClinicalTrials.gov registry entry for NCT00703222 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP is the first listed.
NCT00703222 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00703222 about?
NCT00703222 is a clinical study titled "A Phase I/II Study Of Immunization With Lymphotactin And Interleukin 2 Gene Modified Neuroblastoma Tumor Cells". 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 chemot...
What is the current status of trial NCT00703222?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2008-06. Estimated completion is 2025-05.
What interventions are being tested in trial NCT00703222?
The interventions under investigation include: SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP (BIOLOGICAL), SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 2 SKNLP (BIOLOGICAL).
Who is sponsoring clinical trial NCT00703222?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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