Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance - Full Text View

Sponsored by:	Protherics
Information provided by:	Protherics
ClinicalTrials.gov Identifier:	NCT00219791

Purpose

To evaluate the safety and efficacy of glucarpidase in patients with impaired methotrexate (MTX) clearance owing to MTX-induced renal failure following high-dose MTX therapy, or with intrathecal MTX overdose.

Condition	Intervention	Phase
Neoplasms	Drug: glucarpidase (50 Units/kg)	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Study of Recombinant Carboxypeptidase G2 (CPG2) for the Management of Patients With Delayed Methotrexate (MTX) Clearance or Intrathecal MTX Overdosage

Further study details as provided by Protherics:

Primary Outcome Measures:

Reduction in serum MTX concentration

Secondary Outcome Measures:

serum blood-urea-nitrogen
serum creatinine
creatinine clearance
haematology (complete blood count and differential)
biochemistry (electrolytes, SGOT, SGPT, alkaline phosphatase, bilirubin, total protein)
urinalysis (dip-stick)
MTX-related toxicity
Adverse events
Mortality

Study Start Date:	January 2000
Estimated Study Completion Date:	June 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent by patient or legally valid representative
Patients receiving high-dose MTX (>1 g/m2 body surface area (BSA) given as an infusion over 24 hours) for the treatment of ALL, NHL or a solid tumour (e.g. osteosarcoma)
Age ≥ 18 years
Serum MTX >5 µmol/L 42 hours or later after the start of MTX infusion, or serum MTX >1 μmol/L 42 hours or later after the start of MTX infusion together with renal insufficiency, or serum MTX >0.4 µmol/L 48 hours or later after the start of MTX infusion together with renal insufficiency. Renal insufficiency was defined as serum creatinine >1.5 × the upper limit of normal (ULN) and/or oliguria (urine output < 500 mL/24 hours despite adequate hydration, diuretics and alkalinisation).

Exclusion Criteria:

Pregnant or lactating females
Unwillingness of patient or relative/legal representative to give informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219791

Locations

Germany
Charite - Universitätsmedizin Berlin
Berlin, Germany, 12200

Sponsors and Collaborators

Protherics

Investigators

Principal Investigator:

Thiel Eckhard, Prof. Dr.med.

Charite - Universitätsmedizin Berlin

More Information

Study ID Numbers:	PR001-CLN-rpt002, ek.179-6
Study First Received:	September 15, 2005
Last Updated:	April 5, 2007
ClinicalTrials.gov Identifier:	NCT00219791
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Protherics:

methotrexate
delayed elimination
renal insufficiency
CPG2
Voraxaze

Study placed in the following topic categories:

Folic Acid
Renal Insufficiency
Methotrexate

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists

Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009