Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma

The Hospital for Sick Children

Status and phase

Completed

Phase 3

Conditions

Osteosarcoma

Treatments

Drug: High Dose Methotrexate

Study type

Interventional

Funder types

Other

Identifiers

NCT01176981

1000018144

Details and patient eligibility

About

The primary purpose of this study is to determine the safety and feasibility of delivering HDMTX in an outpatient setting.

Full description

High Dose Methotrexate (HDMTX) is an integral part of osteosarcoma therapy whose main toxicities include myelosuppression, mucositis, nephrotoxicity, and hepatitis. In order to deliver HDMTX therapy safely, patients require urinary alkalinization, hydration, monitoring of renal function, therapeutic drug monitoring, and leucovorin rescue. Due to the required supportive care needs, HDMTX has historically been given as an inpatient. In some centers however, HDMTX is being given safely as an outpatient in order to reduce health care costs, improve patient quality of life and to deliver timely therapy with limited inpatient chemotherapy beds available.

Enrollment

6 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥ 6 years of age;
Localized or metastatic osteosarcoma;
Adequate renal function (GFR > 70 ml/1.73m2) prior to each cycle;
No grade III/IV renal toxicity, mucositis or vomiting with most recent prior inpatient MTX cycle;
Parent and/or patient must be able to provide written consent, and complete Patient Flow Sheets in English.

Exclusion criteria

Patients, in the opinion of the primary healthcare team, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal.
Pregnant females
Breastfeeding females