Minneapolis, Minnesota 55455


Purpose:

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.


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


Study is Available At:


Original ID:

2015LS108


NCT ID:

NCT02605421


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

30 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Masonic Cancer Center, University of Minnesota


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Heather Stefanski, MD
Principal Investigator
Masonic Cancer Center, University of Minnesota
Primary Contact:Kim Nelson
612-273-2925
knelso62@fairview.org
Backup Contact:Heather Stefanski, MD
(612) 624-0123
stef0030@umn.edu

Study Dates

Start Date:June 2016
Completion Date:January 2023
Completion Type:Anticipated
Primary Completion Date:January 2020
Primary Completion Type:Anticipated
Verification Date:April 2019
Last Changed Date:April 23, 2019
First Received Date:November 12, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Progression Free Survival
Time Frame:3 years from first PBSC infusion
Safety Issues:False
Description:Percentage of patients with progression free survial. Kaplan-Meier curves and 95% confidence intervals will be used to estimate.
Outcome Type:Secondary Outcome
Measure:Time to Engraftment
Time Frame:Day 42
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Relapse
Time Frame:3 years from first PBSC infusion
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Overall Survival
Time Frame:3 years from first PBSC infusion
Safety Issues:False
Description:Kaplan-Meier curves and 95% confidence intervals will be used to estimate overall survival.

Study Interventions

Intervention Type:Drug
Name:Thiotepa
Description:Thiotepa by IV once daily for 3 doses on Days -7, -6 and -5. Given as part of Consolidation Course #1 along with Cyclophosphamide.
Arm Name:Patients Treated for Neuroblastoma
Intervention Type:Drug
Name:Cyclophosphamide
Description: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.
Arm Name:Patients Treated for Neuroblastoma
Intervention Type:Drug
Name:Melphalan
Description: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.
Arm Name:Patients Treated for Neuroblastoma
Intervention Type:Drug
Name:Etoposide
Description: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.
Arm Name:Patients Treated for Neuroblastoma
Intervention Type:Drug
Name:Carboplatin
Description: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.
Arm Name:Patients Treated for Neuroblastoma
Intervention Type:Biological
Name:Autologous Stem Cell Infusion
Description:On Day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
Arm Name:Patients Treated for Neuroblastoma
Intervention Type:Biological
Name:Granulocyte colony stimulating factor
Description: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.
Arm Name:Patients Treated for Neuroblastoma
Other Name:G-CSF

Study Arms

Study Arm Type:Experimental
Arm Name:Patients Treated for Neuroblastoma
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Masonic Cancer Center, University of Minnesota

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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