A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose
N/A
N/A
N/A
N/A
N/A
Not Enrolling
Both
Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
Both
Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Supportive Care
Principal Investigator
Brigitte C. Widemann, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000077521
NCT ID:
NCT00018967
Start Date:
November 1993
Completion Date:
Related Keywords:
- Neurotoxicity
- Unspecified Adult Solid Tumor, Protocol Specific
- Unspecified Childhood Solid Tumor, Protocol Specific
- unspecified childhood solid tumor, protocol specific
- unspecified adult solid tumor, protocol specific
- neurotoxicity
- Overdose
- Neurotoxicity Syndromes
- Neoplasms
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 |
