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

Who is this study for? Patients with Neuroblastoma
Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Maximum Age: 30
Healthy Volunteers: f
View:

‣ 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

Locations
United States
Minnesota
Masonic Cancer Center, University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Lisa Burke
lburke3@Fairview.org
612-273-8482
Backup
Ashish Gupta, MBBS, MPH
stef0030@umn.edu
612-626-2961
Time Frame
Start Date: 2016-06
Estimated Completion Date: 2025-12
Participants
Target number of participants: 12
Treatments
Experimental: Patients Treated for Neuroblastoma
Consolidation course #1 consists of thiotepa and cyclophosphamide followed by a PBSC rescue. Consolidation course #2 consists of melphalan, etoposide and carboplatin followed by a second PBSC rescue. Post infusion, patients will receive Granulocyte-Colony Stimulating Factor beginning on Day 0 of each consolidation course.
Sponsors
Leads: Masonic Cancer Center, University of Minnesota

This content was sourced from clinicaltrials.gov

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