Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CCLG-NB-2006-05 | |||
| EUDRACT-2005-000915-80 | |||
| EU-20641 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
Primary
Secondary
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | |||
| doxorubicin hydrochloride | Drug | |||
| topotecan hydrochloride | Drug | |||
| vincristine sulfate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (complete or partial) > 50% after 2 courses of topotecan hydrochloride, vincristine, and doxorubicin hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guy Makin, MD, PhD | Royal Manchester Children's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Child Health at University of Bristol | Bristol | England | BS2 8AE | United Kingdom | ||
| Addenbrooke's Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D004317 | Doxorubicin |
| D019772 | Topotecan |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided