Status:
TERMINATED
Voraxaze for Delayed Methotrexate Clearance
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
BTG International Inc.
Conditions:
Hematologic Malignancy
Solid Tumor
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
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 clea...
Detailed Description
Researchers want to learn how glucarpidase may impact patients' length of stay in the hospital, kidney function, and quality of life. Also, researchers want to learn if glucarpidase may decrease the i...
Eligibility Criteria
Inclusion
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- IRB-approved signed informed consent
Exclusion
- 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
- 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)
- Patients with uncontrolled cardiac disease such as uncontrolled angina, cardiac arrhythmia, or Congestive Heart Failure (CHF) (New York Heart Association (NYHA) 4)
- Patients with known hypersensitivity to any of the components of the study drug
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00424645
Start Date
January 1 2007
End Date
January 1 2008
Last Update
December 6 2012
Active Locations (1)
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1
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030