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

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ClinicalTrials.gov Identifier: NCT00219791
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 11, 2014
Sponsor:
Information provided by:
BTG International Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasms Drug: glucarpidase (50 Units/kg) Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2000
Estimated Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Reduction in serum MTX concentration

Secondary Outcome Measures :
  1. serum blood-urea-nitrogen
  2. serum creatinine
  3. creatinine clearance
  4. haematology (complete blood count and differential)
  5. biochemistry (electrolytes, SGOT, SGPT, alkaline phosphatase, bilirubin, total protein)
  6. urinalysis (dip-stick)
  7. MTX-related toxicity
  8. Adverse events
  9. Mortality


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00219791     History of Changes
Other Study ID Numbers: PR001-CLN-rpt002
ek.179-6
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014

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

Additional relevant MeSH terms:
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
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