Relapsed High Risk Neuroblastoma Patients MedDRA version: 14.1 Level: PT Classification code 10066595 Term: Neuroblastoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: TOPOTECAN
CAS Number: 123948-87-8
Concentration unit: mg/l milligram(s)/litre
Concentration type: up to
Concentration n
Sponsors
A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age 2 months -Performance status : Karnofsky = 60 or Lansky = di 50 -Hematopoietic function: neutrophil > 800/ mm3 and platlet > 75.000 /mm3 -Hepatic and renal function: Creatinin =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Concomitant radiotherapy, chemotherapy or immunomodulation. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to evaluate the percentage of response after a reinduction chemotherapy.;Secondary Objective: Evaluate the Event Free Survival (EFS) and Overall Survival(OS) after relapse;Primary end point(s): Objective Response Rate (ORR) after four courses;Timepoint(s) of evaluation of this end point: The ORR will be calculated every six months for 36 months until 6 months from the date of inclusion of the last patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The 3 years EFS and OS;Timepoint(s) of evaluation of this end point: The EFS/OS will be calculated every six months until 6 months from the date of inclusion of the last patient | — |
Countries
Italy
Contacts
Public ContactOncoematologia
Ospedale Pediatrico Bambino Gesù IRCCS
Outcome results
None listed