Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate

April 29, 2015 updated by: National Cancer Institute (NCI)

A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose

RATIONALE: Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from the toxic effects of chemotherapy.

PURPOSE: Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous system toxic effects in patients given an accidental overdose of intrathecal methotrexate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the effectiveness of carboxypeptidase-G2 rescue in patients who develop life threatening methotrexate (MTX) neurotoxicity following accidental intrathecal MTX overdose.
  • Study the CSF pharmacokinetics of MTX following rescue.

OUTLINE: Patients undergo a lumbar puncture as soon as possible after methotrexate overdose to remove methotrexate and receive a single dose of carboxypeptidase-G2 intrathecally over 5 minutes.

Patients are followed for at least 1 month.

PROJECTED ACCRUAL: A maximum of 10 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Institute for Cancer Research at Westmead Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Princess Margaret Hospital for Children
  • Canada
      • Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Quebec
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 1Z2
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Children's & Women's Hospital of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Children's Hospital of Western Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Montreal Children's Hospital at McGill University Health Center
      • Montreal, Quebec, Canada, H3T 1C5
        • Hopital Sainte Justine
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre at the University of Saskatchewan
  • Switzerland
      • Geneva, Switzerland, 1205
        • Swiss Pediatric Oncology Group Geneva
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • University of South Alabama Mitchell Cancer Institute
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Downey, California, United States, 90242-2814
        • Southern California Permanente Medical Group
      • Loma Linda, California, United States, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Madera, California, United States, 93638-8762
        • Children's Hospital Central California
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • Sacramento, California, United States, 95825
        • Kaiser Permanente Medical Center - Oakland
      • San Diego, California, United States, 92123-4282
        • Children's Hospital and Health Center - San Diego
      • Stanford, California, United States, 94305
        • Stanford Comprehensive Cancer Center - Stanford
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • Alfred I. DuPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2970
        • Children's National Medical Center
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Lee Cancer Care of Lee Memorial Health System
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Clinic
      • Miami, Florida, United States, 33155
        • Miami Children's Hospital
      • Orlando, Florida, United States, 32806
        • Nemours Children's Clinic - Orlando
      • St. Petersburg, Florida, United States, 33701
        • All Children's Hospital
      • Tampa, Florida, United States, 33607
        • St. Joseph's Cancer Institute at St. Joseph's Hospital
      • West Palm Beach, Florida, United States, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
      • Savannah, Georgia, United States, 31403-3089
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 95813
        • Cancer Research Center of Hawaii
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Cancer Center
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Indianapolis Hospital
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Blank Children's Hospital
      • Iowa City, Iowa, United States, 52242-1083
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0293
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Cancer Institute at Ochsner Clinic Foundation
    • Maine
      • Bangor, Maine, United States, 04401
        • CancerCare of Maine at Eastern Maine Medial Center
      • Scarborough, Maine, United States, 04074-9308
        • Maine Children's Cancer Program
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0238
        • C.S. Mott Children's Hospital at University of Michigan Medical Center
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Kalamazoo, Michigan, United States, 49007-5341
        • CCOP - Kalamazoo
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center & Children's Hospital - Fairview
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospitals and Clinics of Minneapolis
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
      • St. Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
      • St. Louis, Missouri, United States, 63104
        • Cardinal Glennon Children's Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68114-4113
        • Children's Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center Cancer Center
      • Morristown, New Jersey, United States, 07962
        • Overlook Hospital
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peter's University Hospital
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, United States, 07503
        • St. Joseph's Hospital and Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-5636
        • University of New Mexico Cancer Research and Treatment Center
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10021-6094
        • Memorial Sloan-Kettering Cancer Center
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • North Carolina
      • Charlotte, North Carolina, United States, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • CCOP - MeritCare Hospital
    • Ohio
      • Akron, Ohio, United States, 44308-1062
        • Children's Hospital Medical Center of Akron
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44195-5217
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, United States, 43205-2696
        • Columbus Children's Hospital
      • Dayton, Ohio, United States, 45404-1815
        • Children's Medical Center - Dayton
      • Youngstown, Ohio, United States, 44501
        • Tod Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Cancer Institute
      • Tulsa, Oklahoma, United States, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Oregon Health & Science University Cancer Institute
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health South Carolina Cancer Center
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System Cancer Center
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • East Tennessee State University Cancer Center at Johnson City Medical Center
      • Knoxville, Tennessee, United States, 37916
        • East Tennessee Children's Hospital
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital
    • Texas
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, United States, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Houston, Texas, United States, 77030-2399
        • Baylor University Medical Center - Houston
      • San Antonio, Texas, United States, 78229-3993
        • Methodist Children's Hospital of South Texas
    • Utah
      • Salt Lake City, Utah, United States, 84113-1100
        • Primary Children's Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center at UV Health System
      • Fairfax, Virginia, United States, 22031
        • Inova Fairfax Hospital
      • Norfolk, Virginia, United States, 23507-1971
        • Children's Hospital of The King's Daughters
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic - Marshfield Center
      • Milwaukee, Wisconsin, United States, 53226
        • Midwest Children's Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Patients who received an intrathecal overdose of methotrexate of 100 mg or more

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No prior anaphylactic reaction to carboxypeptidase-G2 administration

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • Concurrent therapy allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Collaborators

Children's Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1993

Primary Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000077521
  • NCI-92-C-0137N
  • CCG-0923
  • POG-9688
  • NCI-T92-0021N
  • COG-0923
  • COG-P9688

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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