Clinical trial · Interventional
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
NCT00634322CI-TRIAL-00015610terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of enrollment
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| glucarpidase | Drug | — | UNRESOLVED |
| leucovorin | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A
- description
- HDMTX-LV with glucarpidase
- interventionNames
- Drug: glucarpidase
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- HDMTX-LV with placebo
- interventionNames
- Drug: leucovorin
- type
- EXPERIMENTAL
- label
- C
- description
- compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.