Reinduction protocol for patients with high-risk neuroblastoma in first relapse
- Conditions
- Relapsed High Risk Neuroblastoma PatientsMedDRA version: 14.1Level: PTClassification code 10066595Term: Neuroblastoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003092-19-IT
- Lead Sponsor
- A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
-Age<18 years -Neuroblastoma diagnosis -First relapse of high risk neuroblastoma -Life Expectancy > 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 <1.5 normal value (NV) ; Bilirubin total < 1.5 (NV) e AST/ALT < 2.5 NV -Informed Written Consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Concomitant radiotherapy, chemotherapy or immunomodulation. Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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