Status:
COMPLETED
High Dose Chemotherapy and Autologous Transplant for Neuroblastoma
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Neuroblastoma
Eligibility:
All Genders
Up to 30 years
Phase:
NA
Brief Summary
This is a standard of care document, outlining the therapy for children with high risk neuroblastoma who are not eligible for Children's Oncology Group (COG) studies.
Detailed Description
This therapy involves the use of melphalan, etoposide, and carboplatin (consolidation chemotherapy); autologous stem cell rescue, post-transplant radiation therapy and a maintenance phase with Isotret...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Less than 30 years of age at diagnosis of neuroblastoma
- No evidence of disease progression: defined as increase in tumor size of \>25% or new lesions
- Recovery from last induction course of chemotherapy (absolute neutrophil count \> 500 and platelet \> 20,000)
- No uncontrolled infection
- Minimum frozen peripheral blood stem cells (PBSCs) of 2 x 10\^6 CD34 cells/kg for transplant are mandatory and 2 x 10\^6 CD34 cells/kg for back-up are strongly recommended (thus, PBSC of 4 x 106 CD34 cells/kg is encouraged)
- Adequate organ function defined as:
- Hepatic: aspartate aminotransferase (AST) \< 3 x upper limit of institutional normal 8 Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 50%, no clinical congestive heart failure 8 Renal: Creatinine clearance or glomerular filtration rate (GFR) \> 60 mL/min/1.73m\^2 If a creatinine clearance is performed at end induction and the result is \< 100 ml/min/1.73m\^2, a GFR must then be performed using a nuclear blood sampling method or iothalamate clearance method. Camera method is NOT allowed as measure of GFR prior to or during Consolidation therapy for patients with GFR or creatinine clearance of \< 100 ml/min/1.73m\^2
- Exclusion Criteria
- Patients with progressive disease should consider participating in phase I studies since consolidation therapy using the regimen outlined in this document have not been determined to be useful.
- Patients who are delayed in consolidation chemotherapy beyond 8 weeks, and don't meet organ function criteria.
Exclusion
Key Trial Info
Start Date :
March 28 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01526603
Start Date
March 28 2012
End Date
May 30 2023
Last Update
February 26 2024
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455