Osteosarcoma
Conditions
Keywords
osteosarcoma, high dose methotrexate, leucovorin
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
Interventions
DRUGglucarpidase
IV dose based on weight, two doses given for 5 minutes, 24 hours apart
DRUGleucovorin
IV or po given every 6 hours
Sponsors
M.D. Anderson Cancer Center
BTG International Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
8 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients Progressing to Next Chemotherapy Cycle | 1 week after intervention |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High-dose Methotrexate Plus Glucarpidase Then Placebo First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart | 1 |
| High-dose Methotrexate Plus Placebo Then Glucarpidase First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart | 1 |
| Arm C, Compassionate Use of Glucarpidase Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg | 5 |
| Total | 7 |
Baseline characteristics
| Characteristic | High-dose Methotrexate Plus Glucarpidase Then Placebo | High-dose Methotrexate Plus Placebo Then Glucarpidase | Arm C, Compassionate Use of Glucarpidase | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 1 | 0 / 5 |
| serious Total, serious adverse events | 0 / 1 | 1 / 1 | 1 / 5 |
Outcome results
Primary
Patients Progressing to Next Chemotherapy Cycle
Time frame: 1 week after intervention