Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity

NCT00481559 | Unknown

• 1 other identifier: PR001-CLN-pro016
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This protocol is for the treatment of toxic plasma methotrexate concentrations (\>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function

Conditions

Neoplasms

Keywords

Voraxaze; glucarpidase; carboxypeptidase; cancer; lymphoma; leukemia; osteosarcoma; methotrexate; delayed elimination; renal insufficiency; toxicity

Interventions

Voraxaze (glucarpidase) DRUG

50 Units/kg in a bolus intravenous injection over 5 minutes

Also known as: carboxypeptidase, CPG2, CPDG2

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients of any age who are experiencing delayed MTX clearance due to impaired renal function will be eligible to receive Voraxaze if the have toxic plasma MTX concentrations (\>1 micromole per liter).

You may not qualify if:

• Voraxaze is not indicated for use in patients who exhibit the expected clearance of MTX (plasma MTX concentrations within 2 standard deviations of the mean MTX excretion curve specific for the dose of MTX administered) or those with normal or mildly impaired renal function because of the potential risk of sub therapeutic exposure to MTX.
• Patients with known hypersensitivity to Voraxaze (glucarpidase, carboxypeptidases)
• Patients intolerant to lactose in food (e.g., dairy products) can still receive Voraxaze.

Sponsors & Collaborators

• BTG International Inc.: lead
• CTI Clinical Trial and Consulting Services: collaborator

MeSH Terms

Conditions

Neoplasms; Lymphoma; Leukemia; Osteosarcoma; Renal Insufficiency

Interventions

glucarpidase; Carboxypeptidases

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Paul Litka, MD

  BTG (contract)

  STUDY CHAIR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2007
• First Posted: June 1, 2007
• Last Updated: January 17, 2014

Record last verified: 2014-01