Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• AgeNo minimum to 30 Years
• SexAll
• Healthy volunteersNo

You may be able to join if

• Less than 30 years of age at diagnosis of neuroblastoma
• End of Induction disease evaluation demonstrating CR, PR, MR or SD
• Hematopoietic Recovery from last induction course of chemotherapy
• No uncontrolled infection
• 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 (thus, PBSC of no less than 6 x 10^6 CD34 cells/kg is encouraged). These must all be collected prior to the initiation of consolidation.
• 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 norequirement 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
• Recovery from acute toxicities of last cycle of induction chemotherapy
• Appropriate written consent - adult or parent/guardian if patient is < 18 years of age and minor information sheet if patient is > 8 years of age

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

TBF regimen. A regimen consisting of busulfan, fludarabine and thiotepa that is used as a conditioning regimen for hematopoietic stem cell transplantation (HSCT). NCI Drug Dictionary

Treatments listed in the registry

• Thiotepa (Drug): Thiotepa by IV once daily for 3 doses on Days -7, -6 and -5. Given as part of Consolidation Course #1 along with Cyclophosphamide.
• Cyclophosphamide (Drug): Cyclophosphamide by IV once daily for 4 doses on Days -5, -4, -3 and -2. Given as part of Consolidation Course #1 along with Thiotepa.
• Melphalan (Drug): Melphalan by IV once daily for 3 doses on Days -8, -7, and -6. Given as part of Consolidation Course #2 along with Etoposide and Carboplatin.
• Etoposide (Drug): Etoposide by IV once daily for 4 doses on Days -8, -7, -6 and -5. Given as part of Consolidation Course #2 along with Melphalan and Carboplatin.
• Carboplatin (Drug): Carboplatin by IV once daily for 4 doses on Days -8, -7, -6 and -5. Given as part of Consolidation Course #2 along with Etoposide and Melphalan.
• Autologous Stem Cell Infusion (Biological): On Day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
• Granulocyte colony stimulating factor (Biological): Beginning on day 0 after infusion of the PBSC, patients will receive G-CSF SQ or IV (SQ preferred) 5 micrograms/kg once daily and continuing once daily until post-nadir ANC > 2000/μL for 3 consecutive days.

Na · Single Group · masking: None

Main goals

• Progression Free Survival (3 years from first PBSC infusion)

Other goals

• Time to Engraftment
• Relapse
• Overall Survival

Planned enrollment: 12 (estimated).

• Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT02605421
• NCI Drug Dictionary: C875

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 26, 2026. Public record; not medical advice.