Status:
ACTIVE_NOT_RECRUITING
Allogeneic Tumor Cell Vaccination With Oral Metronomic Cytoxan in Patients With High-Risk Neuroblastoma
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Neuroblastoma
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief 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 combin...
Detailed Description
WHAT IS THE OVERALL TREATMENT PLAN AND HOW MANY VACCINATIONS WILL THE PATIENT RECEIVE? There will be several injections of the vaccine scheduled. The first injection will be given 3 days after startin...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Histologically proven high risk neuroblastoma in first or subsequent relapse or with primary refractory disease or inability to complete standard therapy
- Age less than 21 at time of initial diagnosis
- Life expectancy 12 weeks or greater
- Karnofsky or Lansky score of 50 or greater
- Platelet count of 50,000/ul or greater
- ANC greater than 750/ul
- Alk Phos level less than 2.5 x upper limit of normal
- Bilirubin less than 2x normal
- AST less than 3x normal
- Hgb 8.0 or greater
- Creatinine 2 x ULN or less OR GFR greater than 40 ml/min/1.73 m2
- Patient has recovered from last chemotherapy or investigational therapy prior to study enrollment
- Women of child-bearing potential must not be pregnant and take/use effective birth control while participating in the study.
- EXCLUSION CRITERIA:
- Due to the unknown effects of this therapy on a fetus, pregnant women will be excluded from this research
- Women who are breast-feeding
- Known HIV positive subjects since treatment may be immunosuppressive
- Severe intercurrent infection or uncontrolled condition 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
- Previous use of oral cytoxan for more than 2 consecutive months within the last 6 months
- Patients currently receiving any investigational agents or have received any tumor vaccines within the previous six months
- Patients, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01192555
Start Date
September 1 2010
End Date
September 1 2026
Last Update
August 1 2025
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030