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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: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT00703222 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT00703222 record still lists
NCT00703222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00703222's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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