Trial Outcomes & Findings for High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma (NCT NCT00634322)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

1 week after intervention

Results posted on

2014-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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
Overall Study STARTED	1	1	5
Overall Study COMPLETED	1	1	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-dose Methotrexate Plus Glucarpidase Then Placebo n=1 Participants 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	High-dose Methotrexate Plus Placebo Then Glucarpidase n=1 Participants 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	Arm C, Compassionate Use of Glucarpidase n=5 Participants 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	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants	2 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=7 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants	2 Participants n=7 Participants

PRIMARY outcome

Timeframe: 1 week after intervention

Outcome measures

Outcome data not reported

Adverse Events

High-dose Methotrexate Plus Glucarpidase Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High-dose Methotrexate Plus Placebo Then Glucarpidase

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm C, Compassionate Use of Glucarpidase

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	High-dose Methotrexate Plus Glucarpidase Then Placebo n=1 participants at risk 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	High-dose Methotrexate Plus Placebo Then Glucarpidase n=1 participants at risk 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	Arm C, Compassionate Use of Glucarpidase n=5 participants at risk 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
Immune system disorders Febrile neutropenia	0.00% 0/1	100.0% 1/1 • Number of events 1	0.00% 0/5
Investigations Thrombocytopenia	0.00% 0/1	0.00% 0/1	20.0% 1/5 • Number of events 4

Other adverse events

Adverse event data not reported

Additional Information

VP Clinical Development, BTG International

BTG International (Protherics)

Phone: 610-943-3632

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60