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MinorCompletion pushed from Sep 2026 to Jun 2027Eligibility criteria expanded, about 20 words · Secondary endpoints: details revised at 1 of 2 entries · Study description expanded, about 10 words · 1 moreShow 4 more changesShow less
Eligibility criteria expanded, about 20 words
Secondary endpoints: details revised at 1 of 2 entries
Study description expanded, about 10 words
Site details revised
Minor8 versionsRe-verified since Mar 5, 2020, no change to tracked fieldsv18-v25
MinorInterventions: Cytoxan (Drug), Neuroblastoma Vaccine (unmodified SKNLP, with gene-modified SJNB-JF-IL2 and SJNB-JF-LTN neuroblastoma cells) (Biological) to Cytoxan (Drug), Neuroblastoma Vaccine (unmodified SKNLP, with gene-modified SJNB-JF-IL2 and SJNB-JF-LTN neuroblastoma cells (Biological)v17
NotablePrimary endpoints: 2 to 1Interventions: Cytoxan (Cyclophosphamide) (Drug), Neuroblastoma Vaccine (unmodified SKNLP, with gene-modified SJNB-JF-IL2 and SJNB-JF-LTN neuroblastoma… to Cytoxan (Drug), Neuroblastoma Vaccine (unmodified SKNLP, with gene-modified SJNB-JF-IL2 and SJNB-JF-LTN neuroblastoma cells) (Biological) · Secondary endpoints revised (2)v16Show 2 more changesShow less
Interventions: Cytoxan (Cyclophosphamide) (Drug), Neuroblastoma Vaccine (unmodified SKNLP, with gene-modified SJNB-JF-IL2 and SJNB-JF-LTN neuroblastoma… to Cytoxan (Drug), Neuroblastoma Vaccine (unmodified SKNLP, with gene-modified SJNB-JF-IL2 and SJNB-JF-LTN neuroblastoma cells) (Biological)
MinorInterventions: Cytoxan (Drug), Neuroblastoma Vaccine (Biological) to Cytoxan (Cyclophosphamide) (Drug), Neuroblastoma Vaccine (unmodified SKNLP, with gene-modified SJNB-JF-IL2 and SJNB-JF-LTN neuroblastoma…v15
Show 13 earlier versionsHide 13 earlier versions
Minor3 versionsRe-verified since Aug 26, 2015, no change to tracked fieldsv12-v14
MinorEnrollment target: estimated 30 to confirmed 11Primary completion date changed from estimate of Sep 2015 to Jul 2012 · Completion date: Sep 2030 to Sep 2026v11Show 2 more changesShow less
Primary completion date changed from estimate of Sep 2015 to Jul 2012
Completion date: Sep 2030 to Sep 2026
MinorTrial status: Recruiting to Active, Not RecruitingSite details revisedv10Show 1 more changeShow less
Site details revised
MinorSite contact updatedStudy arms: 0 to 1v9Show 1 more changeShow less
Study arms: 0 to 1
MinorSite contact updatedEligibility criteria expanded, about 5 wordsv8Show 1 more changeShow less
MinorCompletion date: Sep 2025 to Sep 2030Eligibility criteria expanded, about 14 words · Study description shortened, about 65 words · Site contact updatedv7Show 3 more changesShow less
NotableTrial status: Not Yet Recruiting to RecruitingSite details revisedv2Show 1 more changeShow less
Site details revised
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.