Study on Intensive Chemotherapy and Stem Cell Rescue for Patients with High-Risk Neuroblastoma

Sponsor: Masonic Cancer Center, University of Minnesota

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02605421

Provider View

This clinical trial is testing a treatment plan for patients with high-risk neuroblastoma, involving two rounds of strong chemotherapy followed by stem cell rescue. The goal is to help patients who have already completed initial chemotherapy to further fight the cancer.

Patient Parameters

Program Overview

This study is designed for patients with high-risk neuroblastoma, a type of cancer that affects nerve cells. It involves giving two rounds of intensive chemotherapy, each followed by a procedure called autologous stem cell rescue. This means that after chemotherapy, patients receive their own previously collected stem cells to help their body recover. The treatment should ideally start within 4-6 weeks after the fifth cycle of initial chemotherapy, but no later than 8 weeks. The aim is to strengthen the fight against cancer after the initial treatment phase.

Eligibility Criteria

  • 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

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