Trial Information

An Open-Label, Multicentre, Phase II Study of TVD as Treatment for Children With Stage 4 Neuroblastoma Failing to Respond to First-Line Treatment According to HR-NBL-01/ E-SIOP [Topotecan-Vincristine-Doxorubicin in Children With Stage 4 Neuroblastoma Failing to Respond to COJEC (TVD)]

OBJECTIVES:

Primary

- Assess whether treatment with topotecan hydrochloride, vincristine, and doxorubicin
hydrochloride can achieve a satisfactory response rate in pediatric patients with stage
4 neuroblastoma that failed to respond to rapid first-line treatment.

Secondary

- Determine time to progression in these patients.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter, open-label study.

Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 and vincristine IV
continuously and doxorubicin hydrochloride IV continuously over 48 hours on days 5 and 6.
Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 9 and continuing
until blood counts recover. Treatment repeats every 21-28 days for 2 courses in the absence
of disease progression or unacceptable toxicity. Patients who achieve partial response (PR)
after two courses of treatment receive an additional two courses. Patients who achieve
complete response or very good PR are treated according to the standard therapy in protocol
SIOP-EUROPE- HR-NBL-1. Patients who fail to achieve PR after 2 courses receive further
treatment at the physician's discretion.

Patients are followed periodically for at least 3 years.

PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study.