Dettagli per singolo studio

DEC-NET Serial number IT488

Published online	27/09/2005 14.01.00
Last updated	10/11/2005 11.32.26

Other protocol ID number
Current trial status	Complete(closed to recruitment of participants: follow-up complete)
Major Disease (ICD9 class)	MALIGNANT NEOPLASM OF ADRENAL GLAND
Experimental drug
EPIRUBICIN Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	1-18 years
Eligibility criteria
Inclusion criteria
Phase I: - histologically or cytologically documented diagnosis of solid tumor or lymphoma that progressed after at least one standard chemiotherapy treatment and for which no further standard therapy exists Phase II: - 1-12 years of age - histologically or cytologically documented diagnosis of progressing or relapsed neuroblastoma after standard first or second line treatment (a therapy which may have involved anthracycline) and for which no potentially curative therapy exists - Presence of at least one measurable lesion, as defined by the .International Neuroblastoma Response Criteria. Phase I and II: - males and females with Karnofsky (patients older than 10 years) or Lansky (patients 10 years old or older) .performance. greater than or equal to 50% with adequate nutritional state (greater than or equal to 3rd weight per height percentile) and life expectancy greater than or equal to 12 weeks - ...
Exclusion criteria
- other chemiotherapy or experimental drug or a concomitant therapy with corticosteroids unless the treatment with a pre-defined dose of corticosteroids was already defined upon entry into the study and no change in dose is expected - radiotherapy greater than 40 Gy at mediastinum - pregnancy or breastfeeding or refusal to use an effective contraceptive - ...
Trial design/methodology
Phase	2
Kind of study	Efficacy Safety Pharmacokinetics
Design	Studio di fase I/II
Purpose of study
Primary objectives: Phase I: definition of the epirubicin dose that will need to be tested in Phase II Phase II: determine the efficacy of epirubicin in children with relapsed or refractory neuroblastoma Secondary objectives: Phase I: evaluate the safety profile of epirubicin in pre-established dosages administered through EV infusion over 6 hours every 3 weeks in children with solid tumors or relapsed or refractory lymphomas; to determine the pharmacokinetic parameters of epirubicin and its epirubicinol derivative in the two different age groups: 1-12 years and 12-18 years; to evaluate response to therapy. Phase II: evaluate the acute toxicity of epirubicin administered at the established dose in paediatric patients with relapsed or refractory neuroblastoma.




Summary of study design, objectives, and ongoing research findings
The study is made up of two phases. Phase I involves a gradual increase in dose to test the safety and evaluate the pharmacokinetics of epirubicin in children in two age groups (1-12 years and 12-18 years) with solid tumors or lymphomas that have relapsed or become refractory. Phase II will evaluate epirubicin.s therapeutic potential in children with relapsed or refractory neuroblastoma. The safety of the doses will be tested on a population of patients that have been previously treated during phase I with the aim to identify the maximum tolerable dose to test during phase II. The patients that have previously received anthracyclines that responded to therapy and with eventual relapse could be included both in phase I or II only if the relapse occurred 6 months or more after completion of their previous chemotherapy treatment.