Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate
- Conditions
- Unspecified Adult Solid Tumor, Protocol SpecificNeurotoxicityUnspecified Childhood Solid Tumor, Protocol Specific
- Registration Number
- NCT00018967
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (103)
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Stanford Comprehensive Cancer Center - Stanford
🇺🇸Stanford, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Blank Children's Hospital
🇺🇸Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
East Tennessee State University Cancer Center at Johnson City Medical Center
🇺🇸Johnson City, Tennessee, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸St. Louis, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Kaplan Cancer Center at St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
Cardinal Glennon Children's Hospital
🇺🇸St. Louis, Missouri, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Lee Cancer Care of Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of South Alabama Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
Tod Children's Hospital
🇺🇸Youngstown, Ohio, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Greenville Hospital System Cancer Center
🇺🇸Greenville, South Carolina, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
University of Virginia Cancer Center at UV Health System
🇺🇸Charlottesville, Virginia, United States
Palmetto Health South Carolina Cancer Center
🇺🇸Columbia, South Carolina, United States
Children's Hospital of Western Ontario
🇨🇦London, Ontario, Canada
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
INOVA Fairfax Hospital
🇺🇸Fairfax, Virginia, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec, Canada
Westmead Institute for Cancer Research at Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Children's Hospital and Health Center - San Diego
🇺🇸San Diego, California, 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
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
New York Medical College
🇺🇸Valhalla, New York, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Health & Science University Cancer Institute
🇺🇸Portland, Oregon, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
🇺🇸Bethesda, Maryland, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
St. Vincent Indianapolis Hospital
🇺🇸Indianapolis, Indiana, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor University Medical Center - Houston
🇺🇸Houston, Texas, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Overlook Hospital
🇺🇸Morristown, New Jersey, United States
St. Joseph's Hospital and Medical Center
🇺🇸Paterson, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
C.S. Mott Children's Hospital at University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Sacramento, California, United States
Nemours Children's Clinic - Orlando
🇺🇸Orlando, Florida, United States
Hackensack University Medical Center Cancer Center
🇺🇸Hackensack, New Jersey, United States
Swiss Pediatric Oncology Group Geneva
🇨🇭Geneva, Switzerland
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
CancerCare of Maine at Eastern Maine Medial Center
🇺🇸Bangor, Maine, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Children's Hospital
🇺🇸Omaha, Nebraska, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Allan Blair Cancer Centre at Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
Montreal Children's Hospital at McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Children's & Women's Hospital of British Columbia
🇨🇦Vancouver, British Columbia, Canada
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Saskatoon Cancer Centre at the University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
🇺🇸Huntington, West Virginia, United States
University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States