A Phase 2 interventional study of glucarpidase and leucovorin in Osteosarcoma, sponsored by BTG International Inc.. Terminated. Open to participants aged 8 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-09-15.
Sponsored by BTG International Inc. · Phase 2, Interventional, and Treatment
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
488 studies on the registry are indexed under Osteosarcoma; 124 are open to participants now.
This study's enrollment of 7 is below the median of 40 across 354 interventional studies indexed under Osteosarcoma.
Browse Osteosarcoma studies →BTG International Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Exclusion Criteria:
HDMTX-LV with glucarpidase
Drug: glucarpidase
HDMTX-LV with placebo
Drug: leucovorin
compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment
Drug: glucarpidase
IV dose based on weight, two doses given for 5 minutes, 24 hours apart
Also known as: Voraxaze, caboxypeptidase G2, CPG2
IV or po given every 6 hours
Also known as: LV
Patients Progressing to Next Chemotherapy Cycle
Time frame: 1 week after intervention
| Milestone | High-dose Methotrexate Plus Glucarpidase Then Placebo | High-dose Methotrexate Plus Placebo Then Glucarpidase | Arm C, Compassionate Use of Glucarpidase |
|---|---|---|---|
| Started | 1 | 1 | 5 |
| Completed | 1 | 1 | 5 |
| Not completed | 0 | 0 | 0 |
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High-dose Methotrexate Plus Glucarpidase Then Placebo | — | 0/1 (0%) | 0/1 (0%) |
| High-dose Methotrexate Plus Placebo Then Glucarpidase | — | 1/1 (100%) | 0/1 (0%) |
| Arm C, Compassionate Use of Glucarpidase | — | 1/5 (20%) | 0/5 (0%) |
| Event | High-dose Methotrexate Plus Glucarpidase Then Placebo | High-dose Methotrexate Plus Placebo Then Glucarpidase | Arm C, Compassionate Use of Glucarpidase |
|---|---|---|---|
| Febrile neutropeniaImmune system disorders | 0/1 | 1/1 | 0/5 |
| ThrombocytopeniaInvestigations | 0/1 | 0/1 | 1/5 |
| Age, Categorical(Participants) | High-dose Methotrexate Plus Glucarpidase Then Placebo | High-dose Methotrexate Plus Placebo Then Glucarpidase | Arm C, Compassionate Use of Glucarpidase | Total |
|---|---|---|---|---|
| <=18 years | 1 | 1 | 3 | 5 |
| Between 18 and 65 years | 0 | 0 | 2 | 2 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | High-dose Methotrexate Plus Glucarpidase Then Placebo | High-dose Methotrexate Plus Placebo Then Glucarpidase | Arm C, Compassionate Use of Glucarpidase | Total |
|---|---|---|---|---|
| Female | 1 | 1 | 3 | 5 |
| Male | 0 | 0 | 2 | 2 |
No study locations are listed for this record.
The record gives a start of Oct 2008, a primary completion of Mar 2009 and a completion of Apr 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2014, 5 years 6 months after primary completion. A results delay was requested in Jul 2011.
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This study is terminated, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Glucarpidase
BTG International Inc.