Response-based Treatment of High-risk Neuroblastoma

Samsung Medical Center

Status and phase

Unknown

Phase 2

Conditions

Newly Diagnosed High Risk Neuroblastoma

Treatments

Drug: Cisplatin

Drug: Isotretinoin

Drug: Doxorubicin

Drug: Interleukin-2

Drug: Ifosfamide

Drug: Carboplatin

Procedure: Tandem HDCT/auto-SCT

Drug: Cyclophosphamide

Drug: Etoposide

Radiation: Radiotherapy

Radiation: MIBG

Study type

Interventional

Funder types

Other

Identifiers

NCT02771743

2015-02-064

Details and patient eligibility

About

The purpose of this study is to improve outcome of high risk neuroblastoma by tailoring the treatment intensity of tandem high dose chemotherapy according to the treatment response to induction chemotherapy.

Full description

Although the outcome of high-risk neuroblastoma improved after the introduction of high-dose chemotherapy and autologous stem cell transplantation (HDCT/autoSCT), the outcome still needs to be unsatisfactory.

In the investigator's previous study, good responders who had greater reduction of tumor volume after induction chemotherapy showed lower relapse-free survival compared to poor responders.Simultaneously, the reduction in tumor volume also was greater in patients who died of treatment related mortality than patients who had relapsed tumors. These findings suggest that tailoring treatment intensity according to the early tumor response to induction chemotherapy may improve patient outcomes. So, in this study investigators tailored the treatment intensity of high dose chemotherapy according to the treatment response to induction chemotherapy.

Enrollment

54 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with newly diagnosed high risk neuroblastoma
Patients with informed consent

Exclusion criteria

Patients with progressive disease or relapse
Patients who underwent high dose chemotherapy before
Patients with organ dysfunction as follows (creatinine elevation > 3 x upper limit of normal, Total bilirubin > 3 x upper limit of normal, aspartate transaminase/alanine transaminase > 5 x upper limit of normal), ejection fraction <40%
Pregnant or nursing women

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

54 participants in 1 patient group

High risk neuroblastoma

Experimental group

Description:

1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen 2. Upfront surgery or surgery after 6 cycles of chemotherapy 3. Peripheral stem cell mobilization after 7 cycles of chemotherapy 4. Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT) * Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT * Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT 5. Radiotherapy after tandem HDCT 6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin

Treatment: