High Dose Chemotherapy and Autologous Transplant for Neuroblastoma

University of Minnesota (UMN)

Status

Completed

Conditions

Neuroblastoma

Treatments

Drug: Isotretinoin (13-cis-retinoic acid)

Drug: Melphalan

Radiation: Radiation therapy

Biological: Autologous stem cell infusion

Drug: Carboplatin

Biological: Granulocyte colony stimulating factor

Drug: Etoposide

Study type

Interventional

Funder types

Other

Identifiers

NCT01526603

2011OC072

MT2011-11C (Other Identifier)

Details and patient eligibility

About

This is a standard of care document, outlining the therapy for children with high risk neuroblastoma who are not eligible for Children's Oncology Group (COG) studies.

Full description

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.

Enrollment

13 patients

Sex

All

Ages

Under 30 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria

Patients with progressive disease should consider participating in phase I studies since consolidation therapy using the regimen outlined in this document have not been determined to be useful.
Patients who are delayed in consolidation chemotherapy beyond 8 weeks, and don't meet organ function criteria.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

Patients Treated for Neuroblastoma

Other group

Description:

According to patient weight and renal function, consolidation chemotherapy using various doses of Melphalan, Etoposide, and Carboplatin followed by autologous stem cell infusion and serial post-transplant Granulocyte Colony Stimulating Factor, radiation therapy and Isotretinoin maintenance therapy.