Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate
Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00018967
Collaborator
Children's Oncology Group (Other)
10
103
0.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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 Design
Study Type:
Interventional
Anticipated Enrollment
:
10 participants
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose
Study Start Date
:
Nov 1, 1993
Actual Primary Completion Date
:
Apr 1, 2007
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | United States | 36604 |
| 2 | Phoenix Children's Hospital | Phoenix | Arizona | United States | 85016 |
| 3 | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 4 | Southern California Permanente Medical Group | Downey | California | United States | 90242-2814 |
| 5 | Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 6 | Children's Hospital Central California | Madera | California | United States | 93638-8762 |
| 7 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
| 8 | Kaiser Permanente Medical Center - Oakland | Sacramento | California | United States | 95825 |
| 9 | Children's Hospital and Health Center - San Diego | San Diego | California | United States | 92123-4282 |
| 10 | Stanford Comprehensive Cancer Center - Stanford | Stanford | California | United States | 94305 |
| 11 | Alfred I. duPont Hospital for Children | Wilmington | Delaware | United States | 19899 |
| 12 | Children's National Medical Center | Washington | District of Columbia | United States | 20010-2970 |
| 13 | Lee Cancer Care of Lee Memorial Health System | Fort Myers | Florida | United States | 33901 |
| 14 | Nemours Children's Clinic | Jacksonville | Florida | United States | 32207 |
| 15 | Miami Children's Hospital | Miami | Florida | United States | 33155 |
| 16 | Nemours Children's Clinic - Orlando | Orlando | Florida | United States | 32806 |
| 17 | All Children's Hospital | St. Petersburg | Florida | United States | 33701 |
| 18 | St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa | Florida | United States | 33607 |
| 19 | Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach | Florida | United States | 33407 |
| 20 | Winship Cancer Institute of Emory University | Atlanta | Georgia | United States | 30322 |
| 21 | Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | United States | 31403-3089 |
| 22 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 95813 |
| 23 | Indiana University Cancer Center | Indianapolis | Indiana | United States | 46202-5289 |
| 24 | St. Vincent Indianapolis Hospital | Indianapolis | Indiana | United States | 46260 |
| 25 | Blank Children's Hospital | Des Moines | Iowa | United States | 50309 |
| 26 | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | United States | 52242-1083 |
| 27 | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-7357 |
| 28 | Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky | United States | 40536-0293 |
| 29 | Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
| 30 | CancerCare of Maine at Eastern Maine Medial Center | Bangor | Maine | United States | 04401 |
| 31 | Maine Children's Cancer Program | Scarborough | Maine | United States | 04074-9308 |
| 32 | Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda | Maryland | United States | 20892-1182 |
| 33 | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 34 | C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor | Michigan | United States | 48109-0238 |
| 35 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201-1379 |
| 36 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 37 | CCOP - Kalamazoo | Kalamazoo | Michigan | United States | 49007-5341 |
| 38 | Children's Hospitals and Clinics of Minneapolis | Minneapolis | Minnesota | United States | 55404 |
| 39 | University of Minnesota Medical Center & Children's Hospital - Fairview | Minneapolis | Minnesota | United States | 55455 |
| 40 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
| 41 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216-4505 |
| 42 | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | United States | 65203 |
| 43 | Children's Mercy Hospital | Kansas City | Missouri | United States | 64108 |
| 44 | Cardinal Glennon Children's Hospital | St. Louis | Missouri | United States | 63104 |
| 45 | Siteman Cancer Center at Barnes-Jewish Hospital | St. Louis | Missouri | United States | 63110 |
| 46 | Children's Hospital | Omaha | Nebraska | United States | 68114-4113 |
| 47 | Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | United States | 07601 |
| 48 | Overlook Hospital | Morristown | New Jersey | United States | 07962 |
| 49 | Saint Peter's University Hospital | New Brunswick | New Jersey | United States | 08901 |
| 50 | Newark Beth Israel Medical Center | Newark | New Jersey | United States | 07112 |
| 51 | St. Joseph's Hospital and Medical Center | Paterson | New Jersey | United States | 07503 |
| 52 | University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | United States | 87131-5636 |
| 53 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
| 54 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021-6094 |
| 55 | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 56 | New York Medical College | Valhalla | New York | United States | 10595 |
| 57 | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | United States | 28232-2861 |
| 58 | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | United States | 28233-3549 |
| 59 | CCOP - MeritCare Hospital | Fargo | North Dakota | United States | 58122 |
| 60 | Children's Hospital Medical Center of Akron | Akron | Ohio | United States | 44308-1062 |
| 61 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229-3039 |
| 62 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195-5217 |
| 63 | Columbus Children's Hospital | Columbus | Ohio | United States | 43205-2696 |
| 64 | Children's Medical Center - Dayton | Dayton | Ohio | United States | 45404-1815 |
| 65 | Tod Children's Hospital | Youngstown | Ohio | United States | 44501 |
| 66 | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | United States | 73104 |
| 67 | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | United States | 74136 |
| 68 | Oregon Health & Science University Cancer Institute | Portland | Oregon | United States | 97239-3098 |
| 69 | Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
| 70 | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213 |
| 71 | Palmetto Health South Carolina Cancer Center | Columbia | South Carolina | United States | 29203 |
| 72 | Greenville Hospital System Cancer Center | Greenville | South Carolina | United States | 29605 |
| 73 | East Tennessee State University Cancer Center at Johnson City Medical Center | Johnson City | Tennessee | United States | 37604 |
| 74 | East Tennessee Children's Hospital | Knoxville | Tennessee | United States | 37916 |
| 75 | St. Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
| 76 | Medical City Dallas Hospital | Dallas | Texas | United States | 75230 |
| 77 | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | United States | 75390 |
| 78 | Baylor University Medical Center - Houston | Houston | Texas | United States | 77030-2399 |
| 79 | Methodist Children's Hospital of South Texas | San Antonio | Texas | United States | 78229-3993 |
| 80 | Primary Children's Medical Center | Salt Lake City | Utah | United States | 84113-1100 |
| 81 | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | United States | 05405 |
| 82 | University of Virginia Cancer Center at UV Health System | Charlottesville | Virginia | United States | 22908 |
| 83 | INOVA Fairfax Hospital | Fairfax | Virginia | United States | 22031 |
| 84 | Children's Hospital of The King's Daughters | Norfolk | Virginia | United States | 23507-1971 |
| 85 | Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington | West Virginia | United States | 25701 |
| 86 | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | United States | 53792-6164 |
| 87 | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | United States | 54449 |
| 88 | Midwest Children's Cancer Center | Milwaukee | Wisconsin | United States | 53226 |
| 89 | Westmead Institute for Cancer Research at Westmead Hospital | Westmead | New South Wales | Australia | 2145 |
| 90 | Princess Margaret Hospital for Children | Perth | Western Australia | Australia | 6001 |
| 91 | Alberta Children's Hospital | Calgary | Alberta | Canada | T3B 6A8 |
| 92 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 1Z2 |
| 93 | Children's & Women's Hospital of British Columbia | Vancouver | British Columbia | Canada | V6H 3V4 |
| 94 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 95 | Children's Hospital of Western Ontario | London | Ontario | Canada | N6A 4G5 |
| 96 | Children's Hospital of Eastern Ontario | Ottawa | Ontario | Canada | K1H 8L1 |
| 97 | Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
| 98 | Montreal Children's Hospital at McGill University Health Center | Montreal | Quebec | Canada | H3H 1P3 |
| 99 | Hopital Sainte Justine | Montreal | Quebec | Canada | H3T 1C5 |
| 100 | Allan Blair Cancer Centre at Pasqua Hospital | Regina | Saskatchewan | Canada | S4T 7T1 |
| 101 | Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
| 102 | Centre Hospitalier Universitaire de Quebec | Quebec | Canada | G1V 4G2 | |
| 103 | Swiss Pediatric Oncology Group Geneva | Geneva | Switzerland | 1205 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
- Children's Oncology Group
Investigators
- Study Chair: Brigitte C. Widemann, MD, National Cancer Institute (NCI)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00018967
Other Study ID Numbers:
- CDR0000077521
- NCI-92-C-0137N
- CCG-0923
- POG-9688
- NCI-T92-0021N
- COG-0923
- COG-P9688
- NCT00001299
First Posted:
Jan 27, 2003
Last Update Posted:
Apr 30, 2015
Last Verified:
Apr 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: