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

NCT01176981 | Completed Phase 3 Results DMC

• 1 other identifier: 1000018144
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteosarcoma

Keywords

pediatrics; Osteosarcoma; Methotrexate; Outpatient

Outcome Measures

Primary Outcomes (1)

• The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission.

  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.

  9 months

Study Arms (1)

HDMTX

EXPERIMENTAL

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

Drug: High Dose Methotrexate

Interventions

High Dose Methotrexate 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).

HDMTX

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Osteosarcoma

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Abha Gupta
• Organization: Hospital for Sick Children

abha.gupta@sickkids.ca

14168137744

Study Officials

• Abha Gupta, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 6, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 28, 2021
• Results First Posted: October 28, 2021

Record last verified: 2021-10

Locations

CA (1)