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Voraxaze for Delayed Methotrexate Clearance

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ClinicalTrials.gov Identifier: NCT00424645
Recruitment Status : Terminated (Sponsor terminated due to low accrual.)
First Posted : January 19, 2007
Results First Posted : January 7, 2011
Last Update Posted : December 6, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Primary Objectives:

  1. To evaluate the efficacy of Glucarpidase (Voraxaze) in increasing the rate of methotrexate (MTX) clearance following high dose MTX treatment in patients with a delayed MTX clearance.
  2. To evaluate the pharmacokinetics (PK) of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance.
  3. To evaluate the safety profile of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance.

Secondary Objectives:

  1. To evaluate the effect of Glucarpidase on the incidence of neutropenic fever and use of intravenous (IV) antibiotics.
  2. To evaluate the effect of Glucarpidase on the length of hospitalization.
  3. To evaluate the effect of Glucarpidase on renal function.
  4. To evaluate the effect of Glucarpidase on Quality of Life (QOL).
  5. To evaluate the anti-glucarpidase antibody response.
  6. To evaluate the efficacy of Glucarpidase following its use in repeated cycles of high dose MTX treatment.

Condition or disease Intervention/treatment Phase
Hematologic Malignancy Solid Tumor Drug: Voraxaze (Glucarpidase) Drug: Placebo Phase 1 Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized, Double-Blind, Placebo Controlled Trial of Voraxaze™ in Patients With a Delayed MTX Clearance
Study Start Date : January 2007
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Voraxaze
Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
Drug: Voraxaze (Glucarpidase)
50 units/kg IV within 12 hours of study eligibility being confirmed.
Other Name: Carboxypeptidease
Placebo Comparator: Placebo
Placebo administered IV following Voraxaze arm.
Drug: Placebo
Administered by IV within 12 hours of study eligibility being confirmed.


Outcome Measures

Primary Outcome Measures :
  1. Patient Response Rate (Percentage) [ Time Frame: Study period 2 years ]
    Response rate defined as proportion of patients that clear methotrexate (MTX) at 15 min and 24-hour post infusion of study drug, Glucarpidase (Voraxaze) to total patient number. Serum MTX levels (standard methods and mass spectrometry) at 15 minutes, 24 hours, or daily until MTX clearance defined as serum MTX level <0.1 µmol/L.


Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with solid tumors and hematologic malignancies, receiving high dose methotrexate (MTX) (> / = 1 g/m^2 up to 14 g/m^2), who have delayed MTX clearance. Delayed MTX clearance is defined as: a) Serum MTX level at 72 +/- 2 hrs from initiation of infusion > / = 0.1 µmol/L for MTX doses 1-3.5 g/m^2 OR b) Serum MTX level at 72 +/- 2 hrs from initiation of infusion > / = 0.3 µmol/L for MTX doses > 3.5 g/m^2
  2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  3. IRB-approved signed informed consent

Exclusion Criteria:

  1. Any medical or psychiatric illness that is deemed by the investigator to be likely to interfere with patient's ability to sign informed consent, cooperate and participate in the study
  2. Patients receiving medications which may interfere with MTX excretion or enhance MTX toxicity (e.g. Penicillins, Cephalosporins, Tetracyclines, Non-Steroidal Anti-inflammatory Agents, Salicylates, Thiazide Diuretics, Bactrim, and Probenecid)
  3. Patients with uncontrolled cardiac disease such as uncontrolled angina, cardiac arrhythmia, or Congestive Heart Failure (CHF) (New York Heart Association (NYHA) 4)
  4. Patients with known hypersensitivity to any of the components of the study drug
Contacts and Locations

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): NCT00424645


Locations
United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
BTG International Inc.
Investigators
Principal Investigator: Saroj Vadhan-Raj, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00424645     History of Changes
Other Study ID Numbers: 2006-0119
First Posted: January 19, 2007    Key Record Dates
Results First Posted: January 7, 2011
Last Update Posted: December 6, 2012
Last Verified: December 2012

Keywords provided by M.D. Anderson Cancer Center:
Hematologic Malignancy
Solid Tumor
Glucarpidase
Voraxaze
Delayed Methotrexate Clearance
Placebo

Additional relevant MeSH terms:
Neoplasms
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