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

Neuroblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02605421
• Other study ID #: 2015LS108
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2016
• Est. completion date: July 2025

Study information

• Verified date: October 2023
• Source: Masonic Cancer Center, University of Minnesota
• Contact: Lisa Burke
• Phone: 612-273-8482
• Email: lburke3[@]Fairview.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• Thiotepa
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
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
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
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
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.

Biological:
• Autologous Stem Cell Infusion
On Day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
• Granulocyte 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.

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Percentage of patients with progression free survial. Kaplan-Meier curves and 95% confidence intervals will be used to estimate.	3 years from first PBSC infusion
Secondary	Time to Engraftment	Defined as an absolute neutrophil count (ANC) greater than or equal to 0.5 x 109/L for three consecutive days by day 42 after first transplant.	Day 42
Secondary	Relapse	Percentage of patients with relapse. Relapse will be defined as any new lesion; increase of any measurable lesion by >25%; previous negative bone is positive.	3 years from first PBSC infusion
Secondary	Overall Survival	Kaplan-Meier curves and 95% confidence intervals will be used to estimate overall survival.	3 years from first PBSC infusion