Prospective, open label, randomized phase II trial to assess a multimodal molecular targeted therapy in children, adolescent and young adults with relapsed or refractory high risk neuroblastoma - RIST-rNB-2011

niversity Hospital of Regensburg0 sites114 target enrollmentApril 16, 2012

ConditionsRelapsed or refractory high risk neuroblastoma Therapeutic area: Diseases [C] - Cancer [C04]

DrugsSprycel Temomedac®Rapamune Irinomedac

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed or refractory high risk neuroblastoma
Sponsor: niversity Hospital of Regensburg
Enrollment: 114
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 16, 2012

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Hospital of Regensburg

Eligibility Criteria

Inclusion Criteria

•Patients with relapsed high\-risk neuroblastoma (stage IV and all MYCN pos. stages) or progressive disease during primary treatment (\=rNB) / Patients with relapsed
•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 \<1%. Contraception must be started at least four weeks before the start of the investigational therapy.
•Females of childbearing age must be willing to abstain from breastfeeding for the duration of the clinical trial and for at least 30 days after discontinuation of the clinical trial.
•Males must agree not to father a child and must use latex condom during any sexual contact with women of childbearing age during and for 6 months after therapy ends or is stopped, even if they have undergone successful vasectomy.
•Willing and able to complete the clinical trial procedures, as described in the protocol
•Non\-smoker for at least the previous 3 months. Smoking is not allowed during the entire study period

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