A phase II study of Topotecan-Vincristine-Doxorubicin (TVD) in children with stage 4 neuroblastoma failing to respond to COJEC - TVD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000915-80-GB

Enrollment

Registered

2005-08-02

Start date

2005-09-06

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma MedDRA version: 9.1 Level: LLT Classification code 10029260 Term: Neuroblastoma

Interventions

Product Name: topotecan Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: TOPOTECAN CAS Number: 123948878 Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Age over 1 year and less than 21 years at the time of enrolment to this study ? Diagnosis of neuroblastoma according to INSS criteria ? Stage 4 neuroblastoma ? Registration and previous treatment on HR-NBL-1 ? Failure to achieve adequate metastatic PR after first-line therapy with rapid COJEC as per HR-NBL-1 criteria (CCLG NB 2002 06, EudraCT 2006-001489-17) ? Neutrophil count greater than 1.0 x 109/l; platelet count > 100 x 109/l ? Creatinine level =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Severe organ dysfunction Anti-tumour chemotherapy in previous 10 days, radiotherapy in previous 30 days HIV infection Active HCV or HBV hepatitis Previous investigational drug therapy in previous 30 days Previous treatment with doxorubicin

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Objective response rate (i.e. CR or PR) > 50%, after two cycles of TVD ;Main Objective: To evaluate the effectiveness of the combination of topotecan, vincristine and doxorubicin in children with stage 4 neuroblastoma that has failed to respond to standard induction chemotherapy;Secondary Objective: To evaluate the toxicity of TVD in children with stage 4 neuroblastoma who have failed to achieve satisfactory response to standard induction chemotherapy and to evaluate the time to progression of disease after treatment with TVD in this group of patients	—

Measure

Time frame

Primary end point(s): Objective response rate (i.e. CR or PR) > 50%, after two cycles of TVD ;Main Objective: To evaluate the effectiveness of the combination of topotecan, vincristine and doxorubicin in children with stage 4 neuroblastoma that has failed to respond to standard induction chemotherapy;Secondary Objective: To evaluate the toxicity of TVD in children with stage 4 neuroblastoma who have failed to achieve satisfactory response to standard induction chemotherapy and to evaluate the time to progression of disease after treatment with TVD in this group of patients

—

Countries

Italy, United Kingdom

Contacts

Public ContactGuy Makin

Children's Cancer and Leukaemia Group

cclgtrials@leicester.ac.uk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026