Protocol of clinical study
Title
Therapy-Optimization Trial and Phase II Study for the Treatment of Relapsed or Refractory of Primitive Neuroectodermal Brain Tumors and Ependymomas in Children and Adolescents
Inclusion Criteria: Disease Characteristics
• Histologically confirmed Medulloblastoma, cerebral PNET or Ependymoma • Refractory or relapsed disease • Measurable disease by MRI or detection of tumor cells in cerebrospinal fluid Patients characteristics • Performance status ECOG ≥ 3 or Karnofsky Status ≥ 40% • Life expectancy ≥ 8 weeks
Hematological:
• Absolute leukocyte count ≥ 2.0 x 10^9 /l • Hemoglobin ≥ 10g/dl • Platelet count ≥ 70 x 10^9/l
Renal:
• Creatinine no greater than 1.5 times UNL • No overt renal disease
Hepatic:
• Bilirubin less than 2.5 times UNL • AST and ALT less than 5 times UNL • No overt hepatic disease • Pulmonary: • No overt pulmonary disease • Cardiovascular: • No overt cardiovascular disease
Other:
• Not pregnant or nursing • Negative pregnancy test • Fertile patients must use effective contraception
Orphanet Database. Clinical trial 2009. http://www.orpha.net/data/eth/DE/ID60629Eng.pdf
• No uncontrolled infection Prior concurrent therapy • More than 2 weeks since prior systemic chemotherapy • More than 4 weeks since prior radiotherapy • No other concurrent anticancer or experimental drugs Examinations required • Examination of lumbar CSF • Cranial and spinal MRI within 14 days prior to start of treatment
Intervention 1: P-HIT-REZ 2005: Active Comparator Carboplatine, Etoposide, Thiotepa, Trofosfamide intravenous chemotherapy
2: P-HIT-REZ 2005: Active Comparator Temozolomide, Etoposide, Thiotepa oral chemotherapy 3: E-HIT-REZ 2005: Experimental Temozolomide, Etoposide, Trofosfamide Phase II Intravent. Etoposide: Experimental Etoposide Phase II
Number of expected inclusions 200 patients
Study start February 2006
Estimated Study Completion January 2016
Study phase Phase II Phase III
Study Design National, multicentre, treatment, randomized, crossover assignment, active control efficacy study
Orphanet Database. Clinical trial 2009. http://www.orpha.net/data/eth/DE/ID60629Eng.pdf