NEUROBLASTOMA AND OTHER PAEDIATRIC SOLID TUMOURS MedDRA version: 9.1 Level: PT Classification code 10029260 MedDRA version: 9.1 Level: PT Classification code 10039491
Conditions
Interventions
Trade Name: TEMODAL
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Temozolomide
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 150-
Trade
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed neuroblastoma, brain tumours, or other solid tumours (at diagnosis, no additional biopsy needs to be performed for the purpose of the study) - Relapsed or refractory tumours in which correct standard treatment approaches have failed - No more than 2 lines of prior chemotherapy - Measurable primary and/or metastatic disease on CT/MRI: at least one bi-dimensionally measurable lesion For patients with neuroblastoma, measurable disease will be defined by the modified International Neuroblastoma Staging System (Brodeur et al.1993) completed with MIBG scoring - Age at inclusion: 6 months to ≤ 20 years - Lansky play score ≥ 70% or ECOG performance status ≤ 1 - Life expectancy ≥ 3 months - Adequate organ function:Adequate haematological function: haemoglobin ≥ 80 g/L, neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 100 x 109/L; in case of bone marrow disease: neutrophils ≥ 0.5 x 109/L and platelets ≥ 75 x 109/L; Adequate renal function: normal creatinine related to patient?s age: 0 ? 1 year: ≤ 40 μmol/L 1 ? 15 years: ≤ 65 μmol/L 15 ? 20 years: ≤ 110 μmol/L Adequate hepatic function: bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN (AST, ALT ≤ 5 x ULN in case of liver metastases) - Wash out of 4 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 6 weeks in case of prior radiotherapy (except palliative radiotherapy on non measurable lesions). Patients must have recovered from the acute toxic effects of all prior therapy before enrolment into the study - Patients previously treated with only one of the 2 drugs are eligible - Able to comply with scheduled follow-up and with management of toxicity - All patients with reproductive potential must practice an effective method of birth control while on study. Female patients aged > 12 years must have a negative pregnancy test within 7 days before study treatment - Written informed consent from patient, parents or legal guardian. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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
Exclusion criteria: Concurrent administration of any other anti-tumour therapy - Serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the patient?s ability to complete the study - History of allergic reaction to the compounds or their solvents - History of allergic reaction to Dacarbazine (DITC) - Galactosemia, Glucose-galactose malabsorption or lactase deficiency - Pregnant or breast feeding young women - Presence of symptomatic brain metastases in patients with solid non-CNS tumours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the response rate of Temozolomide in combination with Topotecan in patients with relapsed or refractory neuroblastoma, and to describe response in patients with relapsed or refractory brain tumours other than medulloblastoma and in patients with relapsed or refractory other solid tumours;Secondary Objective: To determine duration of response, time to progressive disease, time to treatment failure and overall survival - To assess adverse events and toxicity profile of the combination - To evaluate MGMT expression on archived tumour material and correlate with response;Primary end point(s): nd | — |
Countries
Italy
Outcome results
None listed