A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose
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.
Interventional
Masking: Open Label, Primary Purpose: Supportive Care
Brigitte C. Widemann, MD
Study Chair
National Cancer Institute (NCI)
United States: Food and Drug Administration
CDR0000077521
NCT00018967
November 1993
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Hurley Medical Center | Flint, Michigan 48503 |
| Medical City Dallas Hospital | Dallas, Texas 75230 |
| Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
| Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
| Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
| New York Medical College | Valhalla, New York 10595 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Children's Hospital of Orange County | Orange, California 92668 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Children's Mercy Hospital | Kansas City, Missouri 64108 |
| St. Joseph's Hospital and Medical Center | Paterson, New Jersey 07503 |
| Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
| Nemours Children's Clinic | Jacksonville, Florida 32207 |
| Miami Children's Hospital | Miami, Florida 33155-4069 |
| All Children's Hospital | St. Petersburg, Florida 33701 |
| Maine Children's Cancer Program | Scarborough, Maine 04074-9308 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
| Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
| Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
| Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
| Southern California Permanente Medical Group | Downey, California 90242 |
| Children's Hospital Central California | Madera, California 93638-8762 |
| Children's Hospital Medical Center of Akron | Akron, Ohio 44308 |
| Children's Medical Center - Dayton | Dayton, Ohio 45404 |
| Palmetto Health South Carolina Cancer Center | Columbia, South Carolina 29203 |
| East Tennessee Children's Hospital | Knoxville, Tennessee 37901 |
| Children's Hospital of the King's Daughters | Norfolk, Virginia 23507 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Overlook Hospital | Summit, New Jersey 07902-0220 |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
| Kaiser Permanente Medical Center - Oakland | Sacramento, California 95825 |
| Children's Hospital and Health Center - San Diego | San Diego, California 92123-4282 |
| Lee Cancer Care of Lee Memorial Health System | Fort Myers, Florida 33901 |
| Nemours Children's Clinic - Orlando | Orlando, Florida 32806 |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa, Florida 33607 |
| Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach, Florida 33407 |
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
| St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
| Blank Children's Hospital | Des Moines, Iowa 50309 |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
| CancerCare of Maine at Eastern Maine Medial Center | Bangor, Maine 04401 |
| Children's Hospitals and Clinics of Minneapolis | Minneapolis, Minnesota 55404 |
| Hackensack University Medical Center Cancer Center | Hackensack, New Jersey 07601 |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
| Greenville Hospital System Cancer Center | Greenville, South Carolina 29605 |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
| Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
| Methodist Children's Hospital of South Texas | San Antonio, Texas 78229-3993 |
| Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
| Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington, West Virginia 25701 |
| Saint Peter's University Hospital | New Brunswick, New Jersey 08901-1780 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| University of South Alabama Mitchell Cancer Institute | Mobile, Alabama 36604 |
| Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor, Michigan 48109-0286 |
| Children's Hospital | Omaha, Nebraska 68114-4113 |
| Tod Children's Hospital | Youngstown, Ohio 44501 |
| Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
| East Tennessee State University Cancer Center at Johnson City Medical Center | Johnson City, Tennessee 37604 |
| Columbus Children's Hospital | Columbus, Ohio 43205-2696 |
| University of Minnesota Medical Center & Children's Hospital - Fairview | Minneapolis, Minnesota 55455 |
| Oregon Health & Science University Cancer Institute | Portland, Oregon 97239-3098 |
| University of Virginia Cancer Center at UV Health System | Charlottesville, Virginia 22908 |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda, Maryland 20892-1182 |
| Stanford Comprehensive Cancer Center - Stanford | Stanford, California 94305 |
