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NCT01192555 · ClinicalTrials.gov registry record · Phase 1
Allogeneic Tumor Cell Vaccination With Oral Metronomic Cytoxan in Patients With High-Risk Neuroblastoma
A Phase 1 study of Neuroblastoma, sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT01192555 is a Phase 1 study of Neuroblastoma that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 11 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01192555, a Phase 1 study of Neuroblastoma, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
Neuroblastoma is the second most common solid tumor seen in children, but causes approximately 15% of childhood cancer deaths each year. Patients with high-risk disease require treatment with a combination of chemotherapy, surgery, radiation, and stem cell transplant; however, many will have their disease come back within 3 years. Due to this high rate of relapse, this study is being done to investigate an experimental treatment option for children whose disease has returned. This clinical trial is for patients with neuroblastoma that has either come back after treatment or never went away in the first place. A series of immunizations will be administered using a tumor vaccine and add low-dose chemotherapy to be taken by mouth on a daily basis. The hope is that the vaccine will cause the immune system to recognize and kill more types of neuroblastoma tumors. Additionally, the immunizations will be combined with daily low dose chemotherapy. Daily low-dose chemotherapy, also know as metronomic chemotherapy, works by attacking the blood vessels that allow tumors to grow. Using metronomic doses of a drug called cytoxan can also decrease T regulatory cells, a specific type of cell that tumors use to hide from the immune system. The purpose of this study is to test the safety and anti-tumor effect of the tumor cell vaccination plus low dose, metronomic chemotherapy in treating patients with relapsed/refractory neuroblastoma.
Conditions Studied
Interventions
- DRUG Cytoxan
- BIOLOGICAL Neuroblastoma Vaccine (unmodified SKNLP, with gene-modified SJNB-JF-IL2 and SJNB-JF-LTN neuroblastoma cells
Study Locations (1)
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-09 |
| Est. Completion | 2026-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01192555
The ClinicalTrials.gov registry entry for NCT01192555 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (95% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 2 interventions - of which Cytoxan is the first listed.
NCT01192555 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01192555 about?
NCT01192555 is a clinical study titled "Allogeneic Tumor Cell Vaccination With Oral Metronomic Cytoxan in Patients With High-Risk Neuroblastoma". Neuroblastoma is the second most common solid tumor seen in children, but causes approximately 15% of childhood cancer deaths each year. Patients with high-risk disease require treatment with a combination of chemotherapy, surgery, radiation, and stem cell transplant; however, many will have their d...
What is the current status of trial NCT01192555?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2010-09. Estimated completion is 2026-09.
What conditions does trial NCT01192555 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT01192555?
The interventions under investigation include: Cytoxan (DRUG), Neuroblastoma Vaccine (unmodified SKNLP, with gene-modified SJNB-JF-IL2 and SJNB-JF-LTN neuroblastoma cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01192555?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01192555 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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