Spots Global Cancer Trial Database for Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate
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Trial Identification
Brief Title: Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate
Official Title: A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose
Study ID: NCT00018967
Interventions
Study Description
Brief Summary: 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.
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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Southern California Permanente Medical Group, Downey, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States
Children's Hospital Central California, Madera, California, United States
Children's Hospital of Orange County, Orange, California, United States
Kaiser Permanente Medical Center - Oakland, Sacramento, California, United States
Children's Hospital and Health Center - San Diego, San Diego, California, United States
Stanford Comprehensive Cancer Center - Stanford, Stanford, California, United States
Alfred I. duPont Hospital for Children, Wilmington, Delaware, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
Miami Children's Hospital, Miami, Florida, United States
Nemours Children's Clinic - Orlando, Orlando, Florida, United States
All Children's Hospital, St. Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital, Indianapolis, Indiana, United States
Blank Children's Hospital, Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans, Louisiana, United States
CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, United States
Maine Children's Cancer Program, Scarborough, Maine, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office, Bethesda, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
Children's Hospitals and Clinics of Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota Medical Center & Children's Hospital - Fairview, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital, St. Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital, St. Louis, Missouri, United States
Children's Hospital, Omaha, Nebraska, United States
Hackensack University Medical Center Cancer Center, Hackensack, New Jersey, United States
Overlook Hospital, Morristown, New Jersey, United States
Saint Peter's University Hospital, New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
New York Medical College, Valhalla, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
Children's Hospital Medical Center of Akron, Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Columbus Children's Hospital, Columbus, Ohio, United States
Children's Medical Center - Dayton, Dayton, Ohio, United States
Tod Children's Hospital, Youngstown, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
Oregon Health & Science University Cancer Institute, Portland, Oregon, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Palmetto Health South Carolina Cancer Center, Columbia, South Carolina, United States
Greenville Hospital System Cancer Center, Greenville, South Carolina, United States
East Tennessee State University Cancer Center at Johnson City Medical Center, Johnson City, Tennessee, United States
East Tennessee Children's Hospital, Knoxville, Tennessee, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Medical City Dallas Hospital, Dallas, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Baylor University Medical Center - Houston, Houston, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
Primary Children's Medical Center, Salt Lake City, Utah, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
University of Virginia Cancer Center at UV Health System, Charlottesville, Virginia, United States
INOVA Fairfax Hospital, Fairfax, Virginia, United States
Children's Hospital of The King's Daughters, Norfolk, Virginia, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital, Huntington, West Virginia, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Westmead Institute for Cancer Research at Westmead Hospital, Westmead, New South Wales, Australia
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
Alberta Children's Hospital, Calgary, Alberta, Canada
University of Alberta Hospital, Edmonton, Alberta, Canada
Children's & Women's Hospital of British Columbia, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Children's Hospital of Western Ontario, London, Ontario, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, Canada
Centre Hospitalier Universitaire de Quebec, Quebec, , Canada
Swiss Pediatric Oncology Group Geneva, Geneva, , Switzerland
Contact Details
Name: Brigitte C. Widemann, MD
Affiliation: National Cancer Institute (NCI)
Role: STUDY_CHAIR
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