Ewing sarcoma patients MedDRA version: 17.0 Level: PT Classification code 10015560 Term: Ewing's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Cyclophosphamide
CAS Number: 50-18-0
Concentration unit: g gram(
Sponsors
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Diagnosis of histologically confirmed Ewing sarcoma. b) Receiving VIDE or VDC/IE as part of standard clinical treatment. c) Single or double lumen central venous catheter in place. d) Written informed consent. e) Protocol approval by national and local ethics committee, regulatory authority and Trust R&D Departments. Are the trial subjects under 18? yes Number of subjects for this age range: 90 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: a) Receiving non-standard dose chemotherapy. b) Glomerular filtration rate <60 ml/min/1.73m2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective behind this study is to test the hypothesis that the variation seen in the exposure to vincristine, ifosfamide, cyclophosphamide, doxorubicin and etoposide in patients is related to the age of the patient (children, adolescents and adults). This may explain differences in toxicity and/or survival response to these drugs. This information may be used to improve the treatment of patients taking these drugs in the future. ;Secondary Objective: A secondary objective is the use of biological markers measured in the blood to predict levels of toxicity in children and young adults being treated with vincristine, ifosfamide, doxorubicin, cyclophosphamide and etoposide. ;Primary end point(s): To establish pharmacokinetic profiles for vincristine, ifosfamide, doxorubicin, etoposide and cyclophosphamide in adolescent Ewing's sarcoma patients and to compare profiles between children, adolescents and adults. To validate in young people a panel of blood-borne biomarkers which have been shown to be predictive of bone marrow and mucosal toxicity in adults.;Timepoint(s) of evaluation of this end point: Pharmacokinetic parameters for this study population (including age groupings defined within the protocol) will be determined following recruitment of all patients and analysis of samples collected. An interim analysis of data will be carried out following the recruitment of the first 80 patients studied. | — |
Countries
United Kingdom
Contacts
Public ContactGareth Veal
Northern Institute for Cancer Research, Newcastle University
Outcome results
None listed