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The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | High-dose methotrexate, leucovorin, and Voraxaze |
|
| B | Active Comparator | High-dose methotrexate and leucovorin without Voraxaze (glucarpidase) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glucarpidase, high-dose methotrexate, leucovorin | Drug | single intravenous dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of Leucovorin | Geometric mean (6S)-leucovorin area under the plasma concentration vs. time curve from time 0 to the 3-hour time point. | 5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Saunders, MD | Study Chair | |
| Suzanne Kincaid, CCRA | BTG International Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| Good Samaritan Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | A (High-dose Methotrexate, Leucovorin, and Glucarpidase) | Drug: High-dose methotrexate (HDMTX) and leucovorin (LV) with a single bolus intravenous injection of 50 units/kg glucarpidase over 5 minutes. HDMTX followed by intravenous LV administered at doses recommended in the clinical treatment protocols. LV doses administered as recommended in the package insert for Leucovorin Calcium USP for patients with delayed early MTX elimination and/or evidence of acute renal injury, and should be based upon the pre-glucarpidase MTX concentration. LV doses are maintained for at least 48 hours after dosing with glucarpidase. After this it may be administered at doses recommended in the clinical treatment protocols and existing labeling for LV based on post-Voraxaze MTX concentrations. Patients required IV LV rescue therapy with either ≥15 mg or ≥10 mg/m2 every 6 hours. Other Names: Voraxaze, carboxypeptidase G2, high dose methotrexate, leucovorin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| high-dose methotrexate, leucovorin | Drug | standard of care, leucovorin every 6 hours |
|
|
| Los Angeles |
| California |
| 90017 |
| United States |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States |
| Children's Hospital of Orange County | Los Angeles | California | 92868 | United States |
| Oakland's Children's Hospital | Oakland | California | 94609 | United States |
| Stanford University Medical Center & Lucile Packard Children's Hospital | Palo Alto | California | 94304-1812 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| Children's Hospital for Cancer & Blood Disorders | Aurora | Colorado | 80045 | United States |
| St. Joseph's Hospital | Tampa | Florida | 33607 | United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| University of Massachusetts - Umass Memorial Medical Center | Worcester | Massachusetts | 04655 | United States |
| University of MS Medical Center | Jackson | Mississippi | 39216 | United States |
| University of Missouri-Columbia | Columbia | Missouri | 65212 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| St. Elizabeth Regional Medical Center | Lincoln | Nebraska | 68506 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| ECU Brody School of Medicine | Greenville | North Carolina | 27834 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Huntsman Cancer Center | Salt Lake City | Utah | 84112 | United States |
| Children's Hospital and Regional Medical Center | Seattle | Washington | 98105 | United States |
| FG001 | B (High-dose Methotrexate and Leucovorin Without Glucarpidase) | High-dose methotrexate (HDMTX) and leucovorin (LV) without glucarpidase HDMTX followed by intravenous LV should be administered at doses recommended in the clinical treatment protocols and as per standard of care. LV should be given every 6 hours at a dose of ≤25 mg/m2. |
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| NOT COMPLETED |
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Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | A (High-dose Methotrexate, Leucovorin, and Glucarpidase) | High-dose methotrexate, leucovorin, and glucarpidase glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose |
| BG001 | B (High-dose Methotrexate and Leucovorin Without Glucarpidase) | High-dose methotrexate and leucovorin without glucarpidase high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Pre-glucarpidase (Arm A) or Pre-LV (Arm B) methotrexate plasma conc (umol/L) | Mean | Standard Deviation | micromol/L |
|
| 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 | Pharmacokinetics (PK) of Leucovorin | Geometric mean (6S)-leucovorin area under the plasma concentration vs. time curve from time 0 to the 3-hour time point. | 3 participants were excluded from the PK population (all from Arm A), hence why the total participants is 17, not 20. | Posted | Geometric Mean | 95% Confidence Interval | micromol x hour/L | 5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration |
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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 | A (High-dose Methotrexate, Leucovorin, and Glucarpidase) | High-dose methotrexate, leucovorin, and glucarpidase glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose | 3 | 11 | 7 | 11 | ||
| EG001 | B (High-dose Methotrexate and Leucovorin Without Glucarpidase) | High-dose methotrexate and leucovorin without glucarpidase high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours | 0 | 9 | 0 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| hepatic failure | Hepatobiliary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| hypertension | Vascular disorders | Systematic Assessment |
| ||
| flushing | Vascular disorders | Systematic Assessment |
| ||
| hemoglobin decreased | Investigations | Systematic Assessment |
| ||
| ALT increased | Investigations | Systematic Assessment |
| ||
| AST increased | Investigations | Systematic Assessment |
| ||
| serum creatinine increased | Investigations | Systematic Assessment |
| ||
| hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hypomagnesmia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| abdominal pain lower | Gastrointestinal disorders | Systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| oral pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| mucosal inflammation | General disorders | Systematic Assessment |
| ||
| pyrexia | General disorders | Systematic Assessment |
| ||
| burning sensation | Nervous system disorders | Systematic Assessment |
| ||
| hypoesthesia | Nervous system disorders | Systematic Assessment |
| ||
| lethargy | Nervous system disorders | Systematic Assessment |
| ||
| paresthesia | Nervous system disorders | Systematic Assessment |
| ||
| renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| renal impairment | Renal and urinary disorders | Systematic Assessment |
| ||
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| skin disorder | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| liver disorder | Hepatobiliary disorders | Systematic Assessment |
| ||
| confusional state | Psychiatric disorders | Systematic Assessment |
| ||
| tachypnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SVP, Clinical Development | BTG International Inc. | 610-278-1660 | angela.ogden@btgplc.com |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000629556 | glucarpidase |
| D008727 | Methotrexate |
| D002955 | Leucovorin |
| D011623 | gamma-Glutamyl Hydrolase |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D002268 | Carboxypeptidases |
| D020689 | Exopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|