Overview

Will Glucarpidase After Methotrexate Treatment for Bone Sarcoma Lead to Fewer Side Effects and Reduce Chemotherapy Delays?

Status:
Terminated
Trial end date:
2015-06-01
Target enrollment:
0
Participant gender:
All
Summary
Methotrexate is one of the most effective chemotherapy drugs in the treatment of osteosarcoma and some other types of bone sarcoma which are treated the same way as osteosarcoma. However, it frequently leads to sore mouth, tummy pain and increased risk of developing infections. The investigators try to save or "rescue" normal cells from the side effects of methotrexate by giving a drug called folinic acid. Folinic acid is started 24 hours after methotrexate and given regularly until methotrexate levels are really low and not dangerous to normal cells anymore. Despite this rescue, side effects are still a problem and many patients are not well enough to receive subsequent chemotherapy on time. Almost half of the planned chemotherapy cycles are not given on time due to methotrexate side effects. In this study the investigators will examine if adding a drug called glucarpidase to folinic acid is helpful. Glucarpidase is an enzyme that inactivates methotrexate in the blood stream. Lower methotrexate concentration in the blood stream leads to fewer side effects. The investigators would like to see if glucarpidase helps patients to have their chemotherapy on time, by reducing the side effects of methotrexate.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University College, London
Collaborator:
Richard Scowcroft Foundation
Treatments:
Folic Acid
Leucovorin
Levoleucovorin
Methotrexate
Criteria
Inclusion Criteria:

Written informed consent from patient or parent/guardian Diagnosis of high grade
osteosarcoma, localised or metastatic or high grade osteosarcoma as a second malignancy or
spindle cell sarcoma of bone or relapsed high grade osteosarcoma Ability 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

Exclusion Criteria:

Previous treatment with glucarpidase Pregnant or breast feeding women (patients with
reproductive potential of either gender must use contraception*) Concomitant treatment with
agents which interact with methotrexate metabolism or excretion Serous effusions, including
ascites and pleural effusions