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


Phase 1
N/A
N/A
Not Enrolling
Both
Kidney Diseases

Thank you

Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

920134

NCT ID:

NCT00001298

Start Date:

March 1992

Completion Date:

January 2001

Related Keywords:

  • Kidney Diseases
  • Antibody
  • DAMPA
  • Enzyme
  • Kidney
  • Pharmacokinetics
  • Thymidine
  • Toxicity
  • Kidney Diseases

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892