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High Dose Chemotherapy and Autologous Peripheral Blood Stem Cell (PBSC) Rescue for Neuroblastoma: Standard of Care Considerations


N/A
N/A
30 Years
Open (Enrolling)
Both
Neuroblastoma

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Trial Information

High Dose Chemotherapy and Autologous Peripheral Blood Stem Cell (PBSC) Rescue for Neuroblastoma: Standard of Care Considerations


This therapy involves the use of melphalan, etoposide, and carboplatin (consolidation
chemotherapy); autologous stem cell rescue, post-transplant radiation therapy and a
maintenance phase with Isotretinoin (Accutane, 13-cis-retinoic acid) therapy. If available,
patients should also consider post-transplant therapy with cytokines and monoclonal antibody
(ch14.18) on a COG or New Approaches to Neuroblastoma Therapy (NANT) trial.


Inclusion Criteria:



- Less than 30 years of age at diagnosis of neuroblastoma

- No evidence of disease progression: defined as increase in tumor size of >25% or new
lesions

- Recovery from last induction course of chemotherapy (absolute neutrophil count > 500
and platelet > 20,000)

- No uncontrolled infection

- Minimum frozen peripheral blood stem cells (PBSCs) of 2 x 10^6 CD34 cells/kg for
transplant are mandatory and 2 x 10^6 CD34 cells/kg for back-up are strongly
recommended (thus, PBSC of 4 x 106 CD34 cells/kg is encouraged)

- Adequate organ function defined as:

- Hepatic: aspartate aminotransferase (AST) < 3 x upper limit of institutional
normal 8 Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 50%, no
clinical congestive heart failure 8 Renal: Creatinine clearance or glomerular
filtration rate (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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Successful Engraftment

Outcome Description:

The time to neutrophil engraftment will be assessed by standard statistical approaches.

Outcome Time Frame:

Day 42

Safety Issue:

No

Principal Investigator

Michael R. Verneris, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2011OC072

NCT ID:

NCT01526603

Start Date:

March 2012

Completion Date:

February 2018

Related Keywords:

  • Neuroblastoma
  • peripheral blood stem cell transplantation
  • autologous stem cell transplant
  • Neuroblastoma

Name

Location

Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota  55455