Status:
COMPLETED
A Trial of Carboxypeptidase-G2 (CPDG2) and Thymidine for the Management of Patients With Methotrexate Toxicity and Renal Dysfunction
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Kidney Diseases
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
High dose methotrexate with leucovorin rescue has demonstrated activity in numerous malignancies. Although high dose methotrexate is generally well tolerated, unpredictable life-threatening toxicity c...
Detailed Description
High dose methotrexate with leucovorin rescue has demonstrated activity in numerous malignancies. Although high dose methotrexate is generally well tolerated, unpredictable life-threatening toxicity c...
Eligibility Criteria
Patients of any age at risk for life-threatening toxicity following MTX administration secondary to delayed drug excretion as defined by:
Plasma MTX concentration at least 10 micromoles/liter more than 42 hours after the start of the MTX infusion; OR
Creatinine at least 1.5 times the upper limit of normal or creatinine clearance less than 60 ml/sqm/min and delayed MTX excretion documented by plasma MTX concentration measurements (at least 2 standard deviations above the mean) at least 12 hours following MTX administration.
Key Trial Info
Start Date :
March 1 1992
Trial Type :
INTERVENTIONAL
End Date :
January 1 2001
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00001298
Start Date
March 1 1992
End Date
January 1 2001
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892