| DEC-NET Serial number GB545 |
 See also: IT500 |
| Published online | 13/03/2006 12.43.00 |
| Last updated | 02/08/2006 10.20.29 |
| |
| Other protocol ID number | N/A |
| This trial has been approved by an ethics committee |
| Current trial status | Planned (i.e. not yet recruiting participants) |
Target N. of subjects
|
60
|
Major Disease
(ICD9 class) | MALIGNANT NEOPLASM OF ADRENAL GLAND |
| Experimental drug |
TOPOTECAN
Treatment regimen (dosage and duration)
1.5mg/m2/day days 1-5 |
DOXORUBICIN
Treatment regimen (dosage and duration)
22.5mg/m2/day day 5-6, continous 48 hr infusion |
VINCRISTINE
Treatment regimen (dosage and duration)
1mg/m2/day days5-6, continous 48 hr infusion |
| Gender | Both |
| Age (range) | 1-21 years |
Eligibility criteria |
| Inclusion criteria |
| * 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
* Neutrophil count greater than 1.0 x 109/l; platelet count > 100 x 109/l
* Creatinine level < 120¦̀mol/l
* Total bilirubin < 50¦̀mol/l
* AST and ALT < 2.5 SD above institutional normal values
* Written informed consent by the patient, the patient's parents or guardian
* Normal cardiac function on echocardiography
* GFR ¡Ư 60ml/min/1.73m2
|
| Exclusion criteria |
| * Patients with severe organ dysfunction
* Any anti-tumour chemotherapy in the 10 days or radiotherapy in the 30 days preceding enrolment into the study
* HIV infection
* Active HCV or HBV hepatitis
* Previous treatment with other investigational drugs during the 30 days preceding the enrolment into the study
* Previous treatment with doxorubicin
|
Trial design/methodology |
| Phase | 2 |
| Kind of study | Efficacy
Safety
|
| Design | |
| Purpose of study |
| To evaluate the effectiveness of the combination of Topotecan, Vincristine and Doxorubicin in children with stage 4 neuroblastoma who have failed to respond to standard induction chemotherapy. |
| Primary outcomes |
| Response rate after two cycles of TVD. |
| Secondary outcomes |
| Progression free survival from date of study entry until progression, relapse, second primary tumour or death. |
| Summary of study design, objectives, and ongoing research findings |
| A prospective phase II clinical study in multiple UK and European Centres of a new combination of chemotherapy drugs, topotecan, vincristine and doxorubicin (TVD) in children with advanced neuroblastoma who have failed to respond to treatment on the current European high risk neuroblastoma study (HR-NBL-01). |
