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
- 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.
- To evaluate the pharmacokinetics (PK) of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance.
- To evaluate the safety profile of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance.
- To evaluate the effect of Glucarpidase on the incidence of neutropenic fever and use of intravenous (IV) antibiotics.
- To evaluate the effect of Glucarpidase on the length of hospitalization.
- To evaluate the effect of Glucarpidase on renal function.
- To evaluate the effect of Glucarpidase on Quality of Life (QOL).
- To evaluate the anti-glucarpidase antibody response.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|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|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
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.
Administered by IV within 12 hours of study eligibility being confirmed.
- 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.
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
|United States, Texas|
|U.T. M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Saroj Vadhan-Raj, MD||M.D. Anderson Cancer Center|