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| ID | Type | Description | Link |
|---|---|---|---|
| MDACC #2006-0246 |
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Lack of enrollment
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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | HDMTX-LV with glucarpidase |
|
| B | Active Comparator | HDMTX-LV with placebo |
|
| C | Experimental | compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glucarpidase | Drug | IV dose based on weight, two doses given for 5 minutes, 24 hours apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients Progressing to Next Chemotherapy Cycle | 1 week after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pete Anderson, MD, PhD | M.D. Anderson Cancer Center | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | High-dose Methotrexate Plus Placebo Then Glucarpidase |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patients Progressing to Next Chemotherapy Cycle | Posted | 1 week after intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Immune system disorders | Non-systematic Assessment |
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No efficacy endpoints were reported due to early termination (insufficient enrollment).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Development, BTG International | BTG International (Protherics) | 610-943-3632 | janet.rush@btgplc.com |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000629556 | glucarpidase |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
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| leucovorin | Drug | IV or po given every 6 hours |
|
|
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | 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 |
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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 | 1 | 0 | 1 |
| EG002 | 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 | 1 | 5 | 0 | 5 |
| Thrombocytopenia | Investigations | Non-systematic Assessment |
|
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| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D011621 |
| Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |