NCT00703222CompletedPhase 1/2
A Phase I/II Study Of Immunization With Lymphotactin And Interleukin 2 Gene Modified Neuroblastoma Tumor Cells
A Phase I/II Study Of Immunization With Lymphotactin And Interleukin 2 Gene Modified Neuroblastoma Tumor Cells After High-Dose Chemotherapy And Autologous Stem Cell Rescue In Patients With High Risk Neuroblastoma
Source: ClinicalTrials.gov · Last updated 4 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 20 Jun 2008
- Start date
- Jun 2008
- Primary completion date
- May 2011
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Neuroblastoma, Childhood cancers
- NCT number
- NCT00703222
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 7
- From Jun 2008 to the primary completion date, May 2011
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients must not be currently receiving any investigational agents or have received any tumor vaccines within the previous six months
Other illness
- 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
- HIV-positive patients regardless of treatment status
Other
- Pregnant
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.