NCT00424645

Brief Summary

Primary Objectives:

  1. 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. 2.To evaluate the pharmacokinetics (PK) of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance.
  3. 3.To evaluate the safety profile of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance.
  4. 4.To evaluate the effect of Glucarpidase on the incidence of neutropenic fever and use of intravenous (IV) antibiotics.
  5. 5.To evaluate the effect of Glucarpidase on the length of hospitalization.
  6. 6.To evaluate the effect of Glucarpidase on renal function.
  7. 7.To evaluate the effect of Glucarpidase on Quality of Life (QOL).
  8. 8.To evaluate the anti-glucarpidase antibody response.
  9. 9.To evaluate the efficacy of Glucarpidase following its use in repeated cycles of high dose MTX treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
3 years until next milestone

Results Posted

Study results publicly available

January 7, 2011

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

January 17, 2007

Results QC Date

November 9, 2010

Last Update Submit

December 4, 2012

Conditions

Hematologic MalignancySolid Tumor

Keywords

Hematologic MalignancySolid TumorGlucarpidaseVoraxazeDelayed Methotrexate ClearancePlacebo

Outcome Measures

Primary Outcomes (1)

  • Patient Response Rate (Percentage)

    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.

    Study period 2 years

Study Arms (2)

Voraxaze

EXPERIMENTAL

Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.

Drug: Voraxaze (Glucarpidase)

Placebo

PLACEBO COMPARATOR

Placebo administered IV following Voraxaze arm.

Drug: Placebo

Interventions

Voraxaze (Glucarpidase)DRUG

50 units/kg IV within 12 hours of study eligibility being confirmed.

Also known as: Carboxypeptidease
Voraxaze
PlaceboDRUG

Administered by IV within 12 hours of study eligibility being confirmed.

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

glucarpidase

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Saroj Vadhan, MD
Organization
UT MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org

Study Officials

  • Saroj Vadhan-Raj, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2007

First Posted

January 19, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

December 6, 2012

Results First Posted

January 7, 2011

Record last verified: 2012-12

Locations

US(1)