Neuroblastoma and Other pediatric solid tumours. MedDRA version: 9.1 Level: LLT Classification code 10066595 Term: Neuroblastoma recurrent
Conditions
Interventions
Trade Name: Temodal 5mg gélule
Product Name: Temozolomide
Pharmaceutical Form: Capsule, hard
Trade Name: Témodal 20mg gélule
Product Name: Témozolomide
Pharmaceutical Form: Capsule, hard
Trade Name:
Sponsors
Institut Gustave Roussy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically or cytologically confirmed neuroblastoma, medulloblastoma, CNS tumor, or other non-CNS solid tumor (at diagnosis) -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 -Age at inclusion: 6 months to = 20 years -Lansky play score ³ 70% or ECOG performance status = 1- Life expectancy ³ 3 months- Adequate organ function:Adequate hematological function: hemoglobin ³ 80 g/L, neutrophil count ³ 1.0 x 109/L, platelet count ³ 100 x 109/L; in case of bone marrow disease: neutrophils ³ 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/L1 – 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 enrollment 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 antitumor 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 Dacarbazin (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 tumors
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, medulloblastoma or other CNS tumors and to describe response in patients with relapsed or refractory other solid tumors;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 archive tumor material by Immuno histochemistry and correlate with response ;Primary end point(s): The primary endpoint is the percentage of patients achieving complete or partial response, after having received 2 cycles of Temozolomide - Topotecan (8 weeks) | — |
Countries
Austria, France, Netherlands, Spain
Outcome results
None listed