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Topotecan, Vincristine, and Doxorubicin in Treating Young Patients With Refractory Stage 4 Neuroblastoma

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuroblastoma

Intervention: filgrastim (Biological); doxorubicin hydrochloride (Drug); topotecan hydrochloride (Drug); vincristine sulfate (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Children's Cancer and Leukaemia Group

Official(s) and/or principal investigator(s):
Guy Makin, MD, PhD, Study Chair, Affiliation: Royal Manchester Children's Hospital

Summary

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.

Clinical Details

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 design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Objective response rate (complete or partial) > 50% after 2 courses of topotecan hydrochloride, vincristine, and doxorubicin hydrochloride

Secondary outcome:

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

Detailed description: 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.

Eligibility

Minimum age: 1 Year. Maximum age: 20 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Institute of Child Health at University of Bristol, Bristol, England BS2 8AE, United Kingdom

Addenbrooke's Hospital, Cambridge, England CB2 2QQ, United Kingdom

Leeds Cancer Centre at St. James's University Hospital, Leeds, England LS9 7TF, United Kingdom

Royal Liverpool Children's Hospital, Alder Hey, Liverpool, England L12 2AP, United Kingdom

Great Ormond Street Hospital for Children, London, England WC1N 3JH, United Kingdom

Royal Manchester Children's Hospital, Manchester, England M27 4HA, United Kingdom

Sir James Spence Institute of Child Health at Royal Victoria Infirmary, Newcastle-Upon-Tyne, England NE1 4LP, United Kingdom

Queen's Medical Centre, Nottingham, England NG7 2UH, United Kingdom

Children's Hospital - Sheffield, Sheffield, England S10 2TH, United Kingdom

Royal Hospital for Sick Children, Edinburgh, Scotland EH9 1LF, United Kingdom

Royal Hospital for Sick Children, Glasgow, Scotland G3 8SJ, United Kingdom

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2008
Last updated: September 16, 2013

Page last updated: August 23, 2015

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