This trial is active, not recruiting.

Condition neuroblastoma
Treatments filgrastim, doxorubicin hydrochloride, topotecan hydrochloride, vincristine sulfate
Phase phase 2
Sponsor Children's Cancer and Leukaemia Group
Start date March 2008
End date January 2010
Trial size 63 participants
Trial identifier NCT00392340, CCLG-NB-2006-05, CDR0000508641, EU-20641, EUDRACT-2005-000915-80


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

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

Secondary Outcomes

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
time frame:
Toxicity and incidence of adverse events
time frame:

Eligibility Criteria

Male or female participants from 1 year up to 20 years old.

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

Additional Information

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)]
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).