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RecruitingInterventionalPhase 2

Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma

NCT ID: NCT02605421Sponsor: Masonic Cancer Center, University of MinnesotaLast updated: 2025-10-21

Summary

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.

Arms & interventions

  • DrugThiotepa

    Thiotepa by IV once daily for 3 doses on Days -7, -6 and -5. Given as part of Consolidation Course #1 along with Cyclophosphamide.

  • DrugCyclophosphamide

    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.

  • DrugMelphalan

    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.

  • DrugEtoposide

    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.

  • DrugCarboplatin

    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.

  • BiologicalAutologous Stem Cell Infusion

    On Day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.

  • BiologicalGranulocyte colony stimulating factor

    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.

Outcome measures

Primary

  • Progression Free Survival

    Percentage of patients with progression free survial. Kaplan-Meier curves and 95% confidence intervals will be used to estimate.

    Time frame: 3 years from first PBSC infusion

Secondary

  • Time to Engraftment

    Time frame: Day 42

  • Relapse

    Time frame: 3 years from first PBSC infusion

  • Overall Survival

    Time frame: 3 years from first PBSC infusion

Eligibility criteria

Sex: AllAge: Up to 30 YearsHealthy volunteers: No
* 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

Study locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455

Recruiting
Lisa Burke, RN · Contact
612-273-8482lburke3@Fairview.org
Ashish Gupta, MBBS, MPH · Principal Investigator