children with recurrent or refractory medulloblastoma and newly diagnosed high-grade glioma MedDRA version: 8.1 Level: LLT Classification code 10061030 Term: Brain tumour
Conditions
Interventions
Trade Name: CAMPTO
Product Name: irinotecan
Product Code: A596
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: irinotecan
Sponsors
Pfizer Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed tumors 2. Cohort 1: Recurrent or refractory medulloblastoma in which current standard treatment approaches have failed; biopsy is not required for recurrent disease. Cohort 2: Newly-diagnosed high-grade glioma (WHO grade 3 or 4) 3. Measurable primary and/or metastatic disease: at least one bi-dimensionally measurable lesion on MRI 4. No previous treatment with temozolomide or irinotecan 5. Age at inclusion: 6 months to = 18 years 6. Lansky-Play scale = 70% or ECOG performance status = 1 as appropriate based on age 7. Life expectancy = 3 months 8. Adequate organ function: Hematological function: neutrophil count = 1 x 109/L, platelet count = 100 x 109/L, hemoglobin = 8 g/dL. Renal function: creatinine = 1.5 x ULN for age. If serum creatinine is > 1.5 ULN of age, then creatinine clearance (or radioisotope GFR) must be > 70 mL/min/1.73 m². Hepatic function: bilirubin = 1.5 x ULN; AST and ALT = 2.5 x ULN 9. For medulloblastoma: wash out period of 3 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas; 6 weeks in case of prior radiotherapy. Subjects must have recovered from the acute toxic effects of all prior therapy before enrollment into the study 10. Able to comply with scheduled follow-up and with management of toxicity 11. All subjects with reproductive potential must practice an effective method of birth control while on study. Female subjects with childbearing potential must have a negative pregnancy test within 8 days before study treatment 12. Written informed consent from subject, parent(s) or legal guardian(s) provided prior to enrollment in this study Are the trial subjects under 18? yes Number of subjects for this age range: 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
Exclusion criteria: 1. Diagnosis of brainstem glioma 2. Concurrent administration of any other anti-tumor therapy 3. Pre-existing uncontrolled diarrhea 4. Pregnant or breast feeding 5. Current participation in another clinical trial 6. A serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the subject’s ability to complete the study 7. Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the rate of objective confirmed tumor response of irinotecan in combination with temozolomide in children with recurrent or refractory medulloblastoma and in children with newly diagnosed high-grade glioma. ; Secondary Objective: • To determine the duration of tumor response, time to tumor progression (TTP), time to treatment failure (TTF), and overall survival (OS) • To assess the safety and tolerability of the combination of irinotecan and temozolomide ;Primary end point(s): The primary efficacy endpoint is defined as the proportion of subjects who had a documented complete or partial tumor response (occurring within the first 2 or 4 cycles of treatment for glioma and medulloblastoma, respectively) which must be confirmed by a follow-up objective tumor response assessment obtained = 4 weeks after the initial documentation. | — |
Countries
Denmark, France, Italy, Poland, Spain, United Kingdom
Outcome results
None listed