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High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma

Primary Purpose

Osteosarcoma

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
glucarpidase
leucovorin
Sponsored by
BTG International Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteosarcoma focused on measuring osteosarcoma, high dose methotrexate, leucovorin

Eligibility Criteria

8 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • osteosarcoma
  • eligible to receive 2 sequential cycles of HDMTX-LV

Exclusion Criteria:

  • prior administration of glucarpidase
  • progression of disease while on previous MTX treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Arm Label

    A

    B

    C

    Arm Description

    HDMTX-LV with glucarpidase

    HDMTX-LV with placebo

    compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment

    Outcomes

    Primary Outcome Measures

    Patients Progressing to Next Chemotherapy Cycle

    Secondary Outcome Measures

    Full Information

    First Posted
    March 6, 2008
    Last Updated
    September 9, 2014
    Sponsor
    BTG International Inc.
    Collaborators
    M.D. Anderson Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00634322
    Brief Title
    High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma
    Official Title
    Randomized, Blinded, Placebo-Controlled Trial of High Dose Methotrexate With Leucovorin Rescue (HDMTX-LV) With or Without Glucarpidase in Osteosarcoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Terminated
    Why Stopped
    Lack of enrollment
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    BTG International Inc.
    Collaborators
    M.D. Anderson Cancer Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteosarcoma
    Keywords
    osteosarcoma, high dose methotrexate, leucovorin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    7 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    HDMTX-LV with glucarpidase
    Arm Title
    B
    Arm Type
    Active Comparator
    Arm Description
    HDMTX-LV with placebo
    Arm Title
    C
    Arm Type
    Experimental
    Arm Description
    compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment
    Intervention Type
    Drug
    Intervention Name(s)
    glucarpidase
    Other Intervention Name(s)
    Voraxaze, caboxypeptidase G2, CPG2
    Intervention Description
    IV dose based on weight, two doses given for 5 minutes, 24 hours apart
    Intervention Type
    Drug
    Intervention Name(s)
    leucovorin
    Other Intervention Name(s)
    LV
    Intervention Description
    IV or po given every 6 hours
    Primary Outcome Measure Information:
    Title
    Patients Progressing to Next Chemotherapy Cycle
    Time Frame
    1 week after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: osteosarcoma eligible to receive 2 sequential cycles of HDMTX-LV Exclusion Criteria: prior administration of glucarpidase progression of disease while on previous MTX treatment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pete Anderson, MD, PhD
    Organizational Affiliation
    M.D. Anderson Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma

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