Dettagli per singolo studio

DEC-NET Serial number IT500
See also: GB545
Published online	07/10/2005 10.41.00
Last updated	11/08/2006 16.02.46

Other protocol ID number
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	MALIGNANT NEOPLASM OF ADRENAL GLAND
Experimental drug
TOPOTECAN Treatment regimen (dosage and duration) N/A
DOXORUBICIN Treatment regimen (dosage and duration) N/A
Vincristina Treatment regimen (dosage and duration) 1 mg/mq ev per 2 gg (g 5-6)
Gender	Both
Age (range)	1-20 years
Eligibility criteria
Inclusion criteria
Patients with stage 4 neuroblastoma enrolled in the HR-NBL-01/ESIOP protocol who, at the end of the induction phase (COJEC), have not responded well enough to be eligible for R1, or, in other words, whose response is not complete at the metastatic or bone marrow lavel and/or who show more than 3 spots with mlB Scintigraphy
Exclusion criteria
- Patients with severe organ dysfunction - Chemio and radiotherapy outside of the high risk induction phase protocol
Trial design/methodology
Phase	2
Kind of study	Efficacy Safety
Design
Purpose of study
- to evaluate if this therapeutic regimen is capable of achieving a sufficient number of responses in patients with neuroblastoma who did not respond well to COJEC - to evaluate toxicity - to evaluate time to progression




Summary of study design, objectives, and ongoing research findings
In a Phase II study carried out by the Italian Neuroblastoma Group, topotecan was given for 5 consecutive days prior to vincristine and doxorubicin administered simultaneously in a 48-hour continuos infusion. Of 25 patients so treated, 14 achieved PR after 2 cycles with a 56% major response rate. Toxicity was mainly myelosuppression with no toxic deaths recorded. The current study is undertaken to evaluate TVD as salvage therapy in children with high risk Neuroblastoma failing to achieve major response after COJEC induction regimen