Methotrexate pharmacokinetics following administration of recombinant carboxypeptidase-G2 in rhesus monkeys.
P C Adamson, F M Balis, C L McCully...
https://pubmed.ncbi.nlm.nih.gov/1634927Completed
Phase 1
All Genders
ID00001298
A Trial of Carboxypeptidase-G2 (CPDG2) and Thymidine for the Management of Patients With Methotrexate Toxicity and Renal Dysfunction
Led by National Cancer Institute (NCI) · Updated on 2008-03-04
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
High dose methotrexate with leucovorin rescue has demonstrated activity in numerous malignancies. Although high dose methotrexate is generally well tolerated, unpredictable life-threatening toxicity can occur. For patients who have markedly delayed clearance of methotrexate secondary to renal dysfunction, therapeutic options are few and are of limited efficacy. Carboxypeptidase-G2 inactivates methotrexate by hydrolyzing its C-terminal glutamate residue. Carboxypeptidase-G2 could be used to rescue patients with renal dysfunction and delayed methotrexate excretion, as it provides an alternative to renal clearance as a route of elimination.
CONDITIONS
Official Title
A Trial of Carboxypeptidase-G2 (CPDG2) and Thymidine for the Management of Patients With Methotrexate Toxicity and Renal Dysfunction
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Carboxypeptidase-G2 rescue in a patient with high dose methotrexate-induced nephrotoxicity.
B C Widemann, M L Hetherington, R F Murphy...
https://pubmed.ncbi.nlm.nih.gov/8625136Carboxypeptidase-G2, thymidine, and leucovorin rescue in cancer patients with methotrexate-induced renal dysfunction.
B C Widemann, F M Balis, R F Murphy...
https://pubmed.ncbi.nlm.nih.gov/9164227