Voraxaze for Delayed Methotrexate Clearance
This study has been terminated.
(Sponsor terminated due to low accrual.)
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Protherics
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00424645
First received: January 17, 2007
Last updated: December 4, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
Primary Objectives:
- 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.
Secondary Objectives:
- 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 | Intervention | Phase |
|---|---|---|
|
Hematologic Malignancy Solid Tumor |
Drug: Voraxaze (Glucarpidase) Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Randomized, Double-Blind, Placebo Controlled Trial of Voraxaze™ in Patients With a Delayed MTX Clearance |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Patient Response Rate (Percentage) [ Time Frame: Study period 2 years ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 3 |
| Study Start Date: | January 2007 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Protherics
Investigators
| Principal Investigator: | Saroj Vadhan-Raj, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00424645 History of Changes |
| Other Study ID Numbers: | 2006-0119 |
| Study First Received: | January 17, 2007 |
| Results First Received: | November 9, 2010 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Hematologic Malignancy Solid Tumor Glucarpidase |
Voraxaze Delayed Methotrexate Clearance Placebo |
Additional relevant MeSH terms:
|
Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases 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 May 22, 2013