Clinical trial NCT02605421: Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
Official title: Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neuroblastoma
Keywords: High-risk neuroblastoma
Neuroblastoma
Myeloablative chemotherapy
Myeloablative consolidation chemotherapy
Autologous peripheral blood stem cell rescue
PBSC
Autologous stem cell rescue
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 12
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 3 years from first PBSC infusion
Secondary outcomes:
measure: Time to Engraftment
timeFrame: Day 42
measure: Relapse
timeFrame: 3 years from first PBSC infusion
measure: Overall Survival
timeFrame: 3 years from first PBSC infusion
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Ashish Gupta, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
References: