- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00018967
Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate
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
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New South Wales
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Westmead, New South Wales, Australia, 2145
- Westmead Institute for Cancer Research at Westmead Hospital
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Western Australia
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Perth, Western Australia, Australia, 6001
- Princess Margaret Hospital for Children
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Quebec, Canada, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G 1Z2
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Ontario
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London, Ontario, Canada, N6A 4G5
- Children's Hospital of Western Ontario
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for sick children
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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Montreal, Quebec, Canada, H3T 1C5
- Hopital Sainte Justine
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Geneva, Switzerland, 1205
- Swiss Pediatric Oncology Group Geneva
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Alabama
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Mobile, Alabama, United States, 36604
- University of South Alabama Mitchell Cancer Institute
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Arizona
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Phoenix, Arizona, United States, 85016
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, United States, 90242-2814
- Southern California Permanente Medical Group
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Loma Linda, California, United States, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Madera, California, United States, 93638-8762
- Children's Hospital Central California
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Orange, California, United States, 92868
- Children's Hospital of Orange County
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Sacramento, California, United States, 95825
- Kaiser Permanente Medical Center - Oakland
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San Diego, California, United States, 92123-4282
- Children's Hospital and Health Center - San Diego
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Stanford, California, United States, 94305
- Stanford Comprehensive Cancer Center - Stanford
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Delaware
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Wilmington, Delaware, United States, 19899
- Alfred I. duPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, United States, 20010-2970
- Children's National Medical Center
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Florida
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Fort Myers, Florida, United States, 33901
- Lee Cancer Care of Lee Memorial Health System
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Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic
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Miami, Florida, United States, 33155
- Miami Children's Hospital
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Orlando, Florida, United States, 32806
- Nemours Children's Clinic - Orlando
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St. Petersburg, Florida, United States, 33701
- All Children's Hospital
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Tampa, Florida, United States, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, United States, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, United States, 30322
- Winship Cancer Institute of Emory University
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Savannah, Georgia, United States, 31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, United States, 95813
- Cancer Research Center of Hawaii
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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Indianapolis, Indiana, United States, 46260
- St. Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, United States, 50309
- Blank Children's Hospital
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Iowa City, Iowa, United States, 52242-1083
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Kansas City, Kansas, United States, 66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Kentucky
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Lexington, Kentucky, United States, 40536-0293
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
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Maine
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Bangor, Maine, United States, 04401
- CancerCare of Maine at Eastern Maine Medial Center
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Scarborough, Maine, United States, 04074-9308
- Maine Children's Cancer Program
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Maryland
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Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Michigan
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Ann Arbor, Michigan, United States, 48109-0238
- C.S. Mott Children's Hospital at University of Michigan Medical Center
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Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, United States, 48503
- Hurley Medical Center
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Kalamazoo, Michigan, United States, 49007-5341
- CCOP - Kalamazoo
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical Center & Children's Hospital - Fairview
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Minneapolis, Minnesota, United States, 55404
- Children's Hospitals and Clinics of Minneapolis
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
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St. Louis, Missouri, United States, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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St. Louis, Missouri, United States, 63104
- Cardinal Glennon Children's Hospital
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Nebraska
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Omaha, Nebraska, United States, 68114-4113
- Children's Hospital
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center Cancer Center
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Morristown, New Jersey, United States, 07962
- Overlook Hospital
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New Brunswick, New Jersey, United States, 08901
- Saint Peter's University Hospital
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Newark, New Jersey, United States, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, United States, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, United States, 87131-5636
- University of New Mexico Cancer Research and Treatment Center
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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New York, New York, United States, 10021-6094
- Memorial Sloan-Kettering Cancer Center
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Rochester, New York, United States, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Valhalla, New York, United States, 10595
- New York Medical College
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North Carolina
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Charlotte, North Carolina, United States, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, United States, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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North Dakota
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Fargo, North Dakota, United States, 58122
- CCOP - MeritCare Hospital
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Ohio
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Akron, Ohio, United States, 44308-1062
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, United States, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, United States, 44195-5217
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, United States, 43205-2696
- Columbus Children's Hospital
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Dayton, Ohio, United States, 45404-1815
- Children's Medical Center - Dayton
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Youngstown, Ohio, United States, 44501
- Tod Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma University Cancer Institute
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Tulsa, Oklahoma, United States, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Oregon
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Portland, Oregon, United States, 97239-3098
- Oregon Health & Science University Cancer Institute
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Pittsburgh, Pennsylvania, United States, 15213
- Children's Hospital of Pittsburgh
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South Carolina
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Columbia, South Carolina, United States, 29203
- Palmetto Health South Carolina Cancer Center
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Greenville, South Carolina, United States, 29605
- Greenville Hospital System Cancer Center
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Tennessee
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Johnson City, Tennessee, United States, 37604
- East Tennessee State University Cancer Center at Johnson City Medical Center
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Knoxville, Tennessee, United States, 37916
- East Tennessee Children's Hospital
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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Texas
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Dallas, Texas, United States, 75230
- Medical City Dallas Hospital
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Dallas, Texas, United States, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Houston, Texas, United States, 77030-2399
- Baylor University Medical Center - Houston
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San Antonio, Texas, United States, 78229-3993
- Methodist Children's Hospital of South Texas
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Utah
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Salt Lake City, Utah, United States, 84113-1100
- Primary Children's Medical Center
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Vermont
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Burlington, Vermont, United States, 05405
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia Cancer Center at UV Health System
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Fairfax, Virginia, United States, 22031
- Inova Fairfax Hospital
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Norfolk, Virginia, United States, 23507-1971
- Children's Hospital of The King's Daughters
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West Virginia
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Huntington, West Virginia, United States, 25701
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
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Wisconsin
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Madison, Wisconsin, United States, 53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, United States, 53226
- Midwest Children's Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Masking: NONE
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Widemann BC, Balis FM, Shalabi A, Boron M, O'Brien M, Cole DE, Jayaprakash N, Ivy P, Castle V, Muraszko K, Moertel CL, Trueworthy R, Hermann RC, Moussa A, Hinton S, Reaman G, Poplack D, Adamson PC. Treatment of accidental intrathecal methotrexate overdose with intrathecal carboxypeptidase G2. J Natl Cancer Inst. 2004 Oct 20;96(20):1557-9. doi: 10.1093/jnci/djh270.
- Widemann BC, Balis FM, Shalabi A, et al.: Carboxypeptidase-G2 (CPDG2) treatment of accidental intrathecal (IT) methotrexate (MTX) overdose. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-490, 2002.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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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