Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance

This study has been completed.
Sponsor:
Information provided by:
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT00219791
First received: September 15, 2005
Last updated: April 5, 2007
Last verified: September 2005
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Recombinant Carboxypeptidase G2 (CPG2) for the Management of Patients With Delayed Methotrexate (MTX) Clearance or Intrathecal MTX Overdosage

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Charite - Universitätsmedizin Berlin
Berlin, Germany, 12200
Sponsors and Collaborators
BTG International Inc.
Investigators
Principal Investigator: Thiel Eckhard, Prof. Dr.med. Charite - Universitätsmedizin Berlin
  More Information

No publications provided

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

Keywords provided by BTG International Inc.:
methotrexate
delayed elimination
renal insufficiency
CPG2
Voraxaze

Additional relevant MeSH terms:
Neoplasms
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014