Trials / Terminated
TerminatedNCT00634322
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- BTG International Inc. · Academic / Other
- Sex
- All
- Age
- 8 Years – 50 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | glucarpidase | IV dose based on weight, two doses given for 5 minutes, 24 hours apart |
| DRUG | leucovorin | IV or po given every 6 hours |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2009-03-01
- Completion
- 2009-04-01
- First posted
- 2008-03-13
- Last updated
- 2014-09-15
- Results posted
- 2014-09-15
Source: ClinicalTrials.gov record NCT00634322. Inclusion in this directory is not an endorsement.