OncoMatch/Clinical Trials/NCT02605421
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
Is NCT02605421 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for neuroblastoma.
Treatment: Thiotepa · Cyclophosphamide · Melphalan · Etoposide · Carboplatin · Autologous Stem Cell Infusion · Granulocyte colony stimulating factor — This is a phase II single center study to administer two courses of myeloablative consolidation chemotherapy each followed by an autologous peripheral blood stem cell (PBSC) rescue in patients with high-risk neuroblastoma who have completed induction chemotherapy (independent of this study). Ideally, patients should begin consolidation chemotherapy no later than 8 weeks after the start of Induction Cycle #5; however it is strongly recommended to begin consolidation within 4-6 weeks after the start of Induction Cycle #5.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Prior therapy
Must have received: induction chemotherapy — induction
Lab requirements
Blood counts
Hematopoietic Recovery from last induction course of chemotherapy; Minimum frozen PBSCs of 2 x 10^6 CD34 cells/kg for each transplant are mandatory and a PBSC of 2 x 10^6 CD34 cells/kg for back-up are strongly recommended
Kidney function
Creatinine clearance or GFR > 60 mL/min/1.73m^2. If creatinine clearance < 100 ml/min/1.73m^2, GFR must be performed using nuclear blood sampling or iothalamate clearance method. Camera method NOT allowed.
Liver function
AST and ALT < 3 x upper limit of institutional normal; ALT ≤ 3 x ULN for age; total bilirubin ≤ 1.5 x ULN for age, if baseline was normal, > 1.0 1.5 x baseline if baseline was abnormal
Cardiac function
shortening fraction ≥ 27% or ejection fraction ≥ 45%, no clinical congestive heart failure
Adequate organ function defined as: * Hepatic: AST and ALT < 3 x upper limit of institutional normal; ALT ≤ 3 x ULN for age; total bilirubin ≤ 1.5 x ULN for age, if baseline was normal, > 1.0 1.5 x baseline if baseline was abnormal * Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 45%, no clinical congestive heart failure * Pulmonary: no evidence of dyspnea at rest and no requirement for supplemental oxygen * Renal: Creatinine clearance or 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Masonic Cancer Center, University of Minnesota · Minneapolis, Minnesota
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