CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed
Drug / intervention
carboxypeptidase-G2drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00001298
NCT00001298Phase 1Completed

A Trial of Carboxypeptidase-G2 (CPDG2) and Thymidine for the Management of Patients With Methotrexate Toxicity and Renal Dysfunction

National Cancer Institute (NCI)·interventional·Posted Dec 10, 2002·Updated Mar 4, 2008

In Brief

A Phase 1 clinical trial evaluating carboxypeptidase-G2 for Kidney Diseases. Completed, across 1 site.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Diseases
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 10, 2002
Enrollment StartMar 1, 1992
Study CompletionJan 1, 2001
TodayJul 2, 2026
Posted 23.6 years ago

Interventions

carboxypeptidase-G2drug