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

NCT ID: NCT01176981

Last Updated: 2021-10-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteosarcoma

Keywords

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pediatrics Osteosarcoma Methotrexate Outpatient

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HDMTX

This is a single arm study. All subjects enrolled in the study will be in this arm.

Group Type EXPERIMENTAL

High Dose Methotrexate

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Abha Gupta

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abha Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Related Links

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https://pubmed.ncbi.nlm.nih.gov/29965827/

Related Info

Other Identifiers

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1000018144

Identifier Type: -

Identifier Source: org_study_id