Study Stopped
Lack of enrollment
High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma
Randomized, Blinded, Placebo-Controlled Trial of High Dose Methotrexate With Leucovorin Rescue (HDMTX-LV) With or Without Glucarpidase in Osteosarcoma
2 other identifiers
interventional
7
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2008
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
September 15, 2014
CompletedSeptember 15, 2014
September 1, 2014
5 months
March 6, 2008
November 30, 2012
September 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patients Progressing to Next Chemotherapy Cycle
1 week after intervention
Study Arms (3)
A
EXPERIMENTALHDMTX-LV with glucarpidase
B
ACTIVE COMPARATORHDMTX-LV with placebo
C
EXPERIMENTALcompassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment
Interventions
IV dose based on weight, two doses given for 5 minutes, 24 hours apart
Eligibility Criteria
You may qualify if:
- osteosarcoma
- eligible to receive 2 sequential cycles of HDMTX-LV
You may not qualify if:
- prior administration of glucarpidase
- progression of disease while on previous MTX treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BTG International Inc.lead
- M.D. Anderson Cancer Centercollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No efficacy endpoints were reported due to early termination (insufficient enrollment).
Results Point of Contact
- Title
- VP Clinical Development, BTG International
- Organization
- BTG International (Protherics)
Study Officials
- PRINCIPAL INVESTIGATOR
Pete Anderson, MD, PhD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2008
First Posted
March 13, 2008
Study Start
October 1, 2008
Primary Completion
March 1, 2009
Study Completion
April 1, 2009
Last Updated
September 15, 2014
Results First Posted
September 15, 2014
Record last verified: 2014-09