C71
Conditions
Interventions
Group 1: patients with CYP3A4 inducers: 170 mg/m² Irinotecan-Infusion Day 1, 8, 22, 29, 43, 50 + 30 mg Temsirolimus -Infusion start at day 8 on a weekly basis (3 to 6 patients over 50 days)
Group 2:
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Recurrence or progression of a histologically confirmed malignant glioblastoma WHO-grade IV or anaplastic astrocytoma WHO-grade III without pathological safeguard fulfilling magnetic resonance imaging criteria of a glioblastoma - Progressive singular cerebral metastasis of a solid tumor without the option of surgery or irradiation or multiple progressive cerebral metastases after standard irradiation therapy - Remission of reversible adverse reactions of previous systemic therapy - No administration or steady dose of glucocorticoids within at least the last week before the first cerebral MRI - One line of therapy of the recurrent or progressive disease at most, which has to be completed at least 4 weeks, in case of first line administration of nitrosourea 6 weeks, before inclusion - Patient consents to stay in hospital for the first combined administration of Temsirolimus and Irinotecan - Age = 18 years - ECOG Performance Status 0-2 - Estimated life expectancy of at least 3 months - At least one measurable lesion on MRI according to RECIST - Patient must avoid drinking of grapefruit juice during participation in the trial - Signed informed consent - A previous irradiation therapy must be terminated at least 12 weeks before inclusion
Exclusion criteria
Exclusion criteria: - A second malignoma requiring irradiation or chemotherapy - Scheduled surgery within the timeframe of trial conduction - Infratentorial localisation of the tumor - Cardiac arrhythmia requiring anti-arrhythmic therapy - Myocardial infarction 1,5 times the laboratory´s upper limit value - Bilirubin > 1.5 mg/dl - Alkaline phosphatase > 2.5 times the laboratory´s upper limit value - GOT / GPT > 2.5 times the laboratory´s upper limit value - Hereditary fructose intolerance - Inflammatory bowel disease - Ileus - Uncontrolled diabetes - Hypersensitivity to Irinotecan or Temsirolimus - Serious internistic or neurological disease with poor prognosis (e.g. HIV-infection) - Diseases that are associated with repeated vomitting and thus interfere with the oral intake of medication - Psychological, domestic, sociological or geographical circumstances which could interfere significantly with compliance in regard to attending follow-up visits - Concurrent participation in other therapeutic trials - Pregnancy / Breastfeeding - patient did not practice safe contraception, only women of childbearing potential (intrauterine device plus condom, spermicide plus condom or intrauterine device plus spermicide) - Men, whose female cohabitant of childbearing potential does not practice safe contraception (in this case hormonal contraception is regarded as safe) - HIV-Infection - Active drug abuse - Chronic alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determining the maximum tolerable dose (MTD) of Irinotecan and Temsirolimus at combined administration by observing dose-limiting toxicities (DLT). | — |
Secondary
| Measure | Time frame |
|---|---|
| - analysis of the pharmakokinetics and pharmakodynamics of temsirolimus and irinotecan under combined administration on day 1, 8, 15, 22, 29, 36, 43 and 50 - time to progression on day 43 - Overall Survival (OS) - ECOG at screening and on day 1, 8, 15, 22, 29, 36, 43 and 50 | — |
Countries
Germany
Contacts
Public ContactJörg;Heike Hense;Richly
Universitätsklinikum Essen Innere Klinik (Tumorforschung);Universitätsklinikum Essen Innere Klinik (Tumorforschung)
Outcome results
None listed