Trial Outcomes & Findings for Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma (NCT NCT01176981)

Results Overview

Patients will be evaluated prior to and daily during each outpatient HDMTX course, and if one or more of a list of hospitalization criteria are met, the patient will be admitted to hospital to complete that course.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

6 participants

Primary outcome timeframe

9 months

Results posted on

2021-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	HDMTX This is a single arm study. All subjects enrolled in the study will be in this arm. High Dose Methotrexate: Methotrexate will be given by IV at a dose of 12 gram/m2/dose. The patient will receive 4-6 hours of hydration with alkalinization, and then HD MTX will be infused over 4 hours. Following this, the patient will be discharged home to receive continuous intravenous hydration through a portable pump. The patient will return to hospital daily for a comprehensive clinical assessment, IV hydration and antiemetics, MTX level and creatinine monitoring until MTX is cleared (3-4 days).
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HDMTX n=6 Participants This is a single arm study. All subjects enrolled in the study will be in this arm. High Dose Methotrexate: Methotrexate will be given by IV at a dose of 12 gram/m2/dose. The patient will receive 4-6 hours of hydration with alkalinization, and then HD MTX will be infused over 4 hours. Following this, the patient will be discharged home to receive continuous intravenous hydration through a portable pump. The patient will return to hospital daily for a comprehensive clinical assessment, IV hydration and antiemetics, MTX level and creatinine monitoring until MTX is cleared (3-4 days).
Age, Continuous	13.5 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Patients will be evaluated prior to and daily during each outpatient HDMTX course, and if one or more of a list of hospitalization criteria are met, the patient will be admitted to hospital to complete that course.

Outcome measures

Outcome measures
Measure	HD MTX n=72 courses of MTX all patients received outpatient HD MTX
The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission.	0 courses of MTX

Adverse Events

HDMTX

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Abha Gupta

Hospital for Sick Children

Phone: 14168137744

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place