Topotecan, Vincristine, and Doxorubicin in Treating Young Patients With Refractory Stage 4 Neuroblastoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00392340 |
Recruitment Status
: Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted
: October 26, 2006
Last Update Posted
: September 17, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
RATIONALE: Drugs used in chemotherapy, such as topotecan, vincristine, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving topotecan together with vincristine and doxorubicin works in treating young patients with refractory stage 4 neuroblastoma.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuroblastoma | Biological: filgrastim Drug: doxorubicin hydrochloride Drug: topotecan hydrochloride Drug: vincristine sulfate | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 63 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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)] |
Study Start Date : | March 2008 |
Estimated Primary Completion Date : | January 2010 |

- Objective response rate (complete or partial) > 50% after 2 courses of topotecan hydrochloride, vincristine, and doxorubicin hydrochloride
- Progression-free survival at the time of local progression or relapse, progression of pre-existing metastases, metastatic relapse, second primary malignancy, or death from any cause
- Toxicity and incidence of adverse events

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 1 Year to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Diagnosis of stage 4 neuroblastoma
- Failed to achieve adequate metastatic partial response after first-line therapy while enrolled on protocol SIOP-EUROPE-HR-NBL-1
PATIENT CHARACTERISTICS:
- Neutrophil count > 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.36 mg/dL
- Bilirubin ≤ 2.92 mg/dL
- AST and ALT < 2.5 times upper limit of normal
- Glomerular filtration rate ≥ 60 mL/min
- Normal cardiac function on echocardiography
- No severe organ dysfunction
- No active hepatitis C or hepatitis B virus positivity
- No HIV infection
PRIOR CONCURRENT THERAPY:
- No anti-tumor chemotherapy within the past 10 days
- No radiotherapy within the past 30 days
- No other investigational drugs within the past 30 days
- No prior doxorubicin hydrochloride

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392340
United Kingdom | |
Institute of Child Health at University of Bristol | |
Bristol, England, United Kingdom, BS2 8AE | |
Addenbrooke's Hospital | |
Cambridge, England, United Kingdom, CB2 2QQ | |
Leeds Cancer Centre at St. James's University Hospital | |
Leeds, England, United Kingdom, LS9 7TF | |
Royal Liverpool Children's Hospital, Alder Hey | |
Liverpool, England, United Kingdom, L12 2AP | |
Great Ormond Street Hospital for Children | |
London, England, United Kingdom, WC1N 3JH | |
Royal Manchester Children's Hospital | |
Manchester, England, United Kingdom, M27 4HA | |
Sir James Spence Institute of Child Health at Royal Victoria Infirmary | |
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
Queen's Medical Centre | |
Nottingham, England, United Kingdom, NG7 2UH | |
Children's Hospital - Sheffield | |
Sheffield, England, United Kingdom, S10 2TH | |
Royal Hospital for Sick Children | |
Edinburgh, Scotland, United Kingdom, EH9 1LF | |
Royal Hospital for Sick Children | |
Glasgow, Scotland, United Kingdom, G3 8SJ |
Study Chair: | Guy Makin, MD, PhD | Royal Manchester Children's Hospital |
ClinicalTrials.gov Identifier: | NCT00392340 History of Changes |
Other Study ID Numbers: |
CDR0000508641 CCLG-NB-2006-05 EUDRACT-2005-000915-80 EU-20641 |
First Posted: | October 26, 2006 Key Record Dates |
Last Update Posted: | September 17, 2013 |
Last Verified: | June 2009 |
Keywords provided by National Cancer Institute (NCI):
recurrent neuroblastoma disseminated neuroblastoma |
Additional relevant MeSH terms:
Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Doxorubicin Liposomal doxorubicin Vincristine |
Topotecan Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Topoisomerase I Inhibitors |