Bone Sarcoma MedDRA version: 17.0 Level: PT Classification code 10006007 Term: Bone sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Glucarpidase (VoraxazeTM)
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Glucarpidase
CAS Number: 9074-87-7
Other descriptive name: Carboxypeptidase G2
Concen
Sponsors
UCL University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent of patient or parent/guardian Diagnosis of high grade osteosarcoma, localised or metastatic or high grade osteosarcoma as a second maligancy or spindle cell sarcoma of bone or relapsed high grade osteosarcoma Age: 5-50 years at registration Patients able to comply with study and follow up procedures (WHO performance scale 0-2) No concomitant anti-cancer or investigational drugs during the study and complete resolution of toxicity related to previous treatment Life expectancy of at least 3 months Haematopoietic function: Absolute neutrophil count =1 x109/L, Platelets =75 x109/L Hepatic function: Bilirubin =1.5 x ULN, Renal function: Glomerular Filtration Rate (radioisotope) = 70 ml/min/1.73m2 Are the trial subjects under 18? yes Number of subjects for this age range: 32 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who previously received glucarpidase Pregnant or breast feeding women (patients with reproductive potential of either gender must use contraception, as described in section 5.2 of the protocol) Concomitant treatment with agents which interact with methotrexate metabolism or excretion Serous effusions including ascites and pleural effusions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether glucarpidase rescue after high-dose methotrexate reduces delay to subsequent cycle of chemotherapy due to methotrexate toxicity;Secondary Objective: 1.To investigate whether glucarpidase rescue after high-dose methotrexate reduces the incidence, severity and duration of methotrexate associated adverse effects 2.To study the pharmacokinetics of methotrexate and 4-deoxy-4-amino-N10-methylpteroic acid (DAMPA) after glucarpidase administration 3.To evaluate any adverse effects associated with the use of glucarpidase 4.To investigate the economic impact of using glucarpidase versus standard rescue 5.To investigate the effect of glucarpidase on the quality of life of patients treated with high dose methotrexate 6.To assess the anti-glucarpidase antibody response ;Primary end point(s): Assessment of fitness to receive chemotherapy on day 15 of each cycle (fitness criteria described in section 8 of the protocol);Timepoint(s) of evaluation of this end point: day-7-0, day 1, day 2, day 8, Day 9, Day 15, day 22, day 23, day 29, day 30, day 36, | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence of methotrexate-associated toxicity (CTCAE v3.0 grade =2) 2. Serum methotrexate and DAMPA concentrations 3. Anti-glucarpidase IgG antibody response and neutralisation of glucarpidase activity 4. Number of days required in hospital per cycle and total dose of folinic acid required per cycle 5.Quality of life assessment (QLQ-C30 version 3, FACT-G and PedsQL 3.0 cancer module acute version) ;Timepoint(s) of evaluation of this end point: day-7-0, day 1, day 2, day 8, Day 9, Day 15, day 22, day 23, day 29, day 30, day 36, Day 51, day 111, day 201 | — |
Countries
United Kingdom
Contacts
Public ContactDr Jeremy Whelan
University College London Hospital NHS Foundation Trust
Outcome results
None listed