Relapsed or refractory high-grade pineoblastoma
Conditions
Interventions
Trade Name: Sprycel
Product Name: Sprycel
Pharmaceutical Form: Film-coated tablet
Trade Name: Temomedac
Product Name: Temomedac
Pharmaceutical Form: Capsule, hard
Trade Name: Rapamune
Product Name:
Sponsors
University Hospital of Regensburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with relapsed high-grade pineoblastome (=rPB) and all of the following criteria will be considered for admission to the clinical trial: • Children, adolescents and young adults 0 months to 25 years • Signed written informed consent (patient or his/her parents/legal guardian) • Females of childbearing age must have a negative urine pregnancy test prior to starting the study drug. The first pregnancy test must be performed within 10-14 days prior to the start of the study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug. The subject may not receive the study drug until the investigator has verified that the results of these pregnancy tests are negative. • Females of childbearing age must comply with the institutional standards of birth control with a pearl index =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients presenting with any of the following criteria will not be included in this clinical trial: • Pregnancy, nursing • Patients who suffered from a thrombotic event and need anticoagulation (i.e. coumadine derivatives or low molecular weight heparin derivatives, LMWH) • Patients with cardiac arrhythmias especially prolonged QT • Patients with chronic inflammatory bowel diseases and/or bowel obstruction • Patients with bilirubin serum levels 1,5 fold above the upper normal limit • Vaccination with a live virus vaccine during the clinical trial • Impaired liver function and/or impaired renal function (hepatic and renal index parameter two times above normal range; see below) • Potentially unreliable subjects, probably non compliant subjects and those judged by the investigator to be unsuitable for the study • Doubts about the patient’s cooperation • Any contraindications or known hypersensitivity to the IMPs or to any of the other components: (see SPC ”Fachinformation”) • Known allergic reactions to the treatment medication • Patients who were treated with radiation and/or chemotherapy for any other oncological condition • Participation in any other interventional phase I to III trial • Sexually active patients who refuse to use contraception according to the institutional requirements • Patients with extremely poor general condition (Karnofsky or Lansky score 500 msec / QTc>60 msec baseline • Patients with hepatitis B reactivation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is the evaluation of response of rPB in children, adolescents and young adults to the RIST protocol.;Secondary Objective: Secondary objectives are • Overall survival • Response rate (RR) after 4 and 8 courses of irinotecan and temozolomide in the RIST treatment arm • Toxicity of this combination of drugs in children, adolescents and young adults with rPB • Duration of response of this treatment regimen • Safety and tolerability of the investigational treatment • Assessment of quality of life ;Primary end point(s): The primary endpoint is progression-free survival (PFS), which is defined as the time interval between randomization and date of progression according to • Imaging criteria to o MRI, CT or o CSF evaluations or • date of death of any cause. Patients with no progression until end of study or patients lost to follow up will be classified as censored cases at the latest date they will be confirmed to be progression free.;Timepoint(s) of evaluation of this end point: The primary endpoint of the study, progression free survival will be investigated after 8 completed I/T-courses (approx. 20 weeks). The patients are then followed in 3-monthly intervals until one year after medical treatment was finished. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall survival (OS) • Response to the investigational treatment after 4 and 8 courses of I/T and 1-year-follow-up in the RIST treatment arm • Duration until adequate response to this treatment regimen • Assessment of quality of life (Lansky and Karnofsky Scores) ;Timepoint(s) of evaluation of this end point: -after 4 completed I/T-courses (8 weeks), after 8 completed 8 I/T-courses (20 weeks) and in 3-monthly intervals until one year after medical treatment was finished. - quality of life will be investigated before start of treatment and then in 6-monthly intervals until one year after medical treatment was finished. | — |
Countries
Germany
Contacts
Public ContactSPOH Dokumentation
University Hospital of Regensburg
Outcome results
None listed