Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate

NCT00018967 | Completed

• 7 other identifiers: CDR0000077521NCI-92-C-0137NCCG-0923POG-9688NCI-T92-0021NCOG-0923COG-P9688
• Study Type: interventional
• Target: 10
• Locations: 4 countries
• Sites: 103

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.

Conditions

Neurotoxicity; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific; unspecified adult solid tumor, protocol specific; neurotoxicity

Interventions

glucarpidase DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Children's Oncology Group: collaborator

Study Sites (103)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Southern California Permanente Medical Group

Downey, California, 90242-2814, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Children's Hospital Central California

Madera, California, 93638-8762, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Kaiser Permanente Medical Center - Oakland

Sacramento, California, 95825, United States

Location

Children's Hospital and Health Center - San Diego

San Diego, California, 92123-4282, United States

Location

Stanford Comprehensive Cancer Center - Stanford

Stanford, California, 94305, United States

Location

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19899, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Lee Cancer Care of Lee Memorial Health System

Fort Myers, Florida, 33901, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Nemours Children's Clinic - Orlando

Orlando, Florida, 32806, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

St. Joseph's Cancer Institute at St. Joseph's Hospital

Tampa, Florida, 33607, United States

Location

Kaplan Cancer Center at St. Mary's Medical Center

West Palm Beach, Florida, 33407, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 95813, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

St. Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

Location

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1083, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0293, United States

Location

Ochsner Cancer Institute at Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

CancerCare of Maine at Eastern Maine Medial Center

Bangor, Maine, 04401, United States

Location

Maine Children's Cancer Program

Scarborough, Maine, 04074-9308, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

C.S. Mott Children's Hospital at University of Michigan Medical Center

Ann Arbor, Michigan, 48109-0238, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-5341, United States

Location

Children's Hospitals and Clinics of Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

University of Minnesota Medical Center & Children's Hospital - Fairview

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Children's Hospital

Omaha, Nebraska, 68114-4113, United States

Location

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Overlook Hospital

Morristown, New Jersey, 07962, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, 07503, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-5636, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021-6094, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308-1062, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195-5217, United States

Location

Columbus Children's Hospital

Columbus, Ohio, 43205-2696, United States

Location

Children's Medical Center - Dayton

Dayton, Ohio, 45404-1815, United States

Location

Tod Children's Hospital

Youngstown, Ohio, 44501, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Oregon Health & Science University Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Palmetto Health South Carolina Cancer Center

Columbia, South Carolina, 29203, United States

Location

Greenville Hospital System Cancer Center

Greenville, South Carolina, 29605, United States

Location

East Tennessee State University Cancer Center at Johnson City Medical Center

Johnson City, Tennessee, 37604, United States

Location

East Tennessee Children's Hospital

Knoxville, Tennessee, 37916, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

Baylor University Medical Center - Houston

Houston, Texas, 77030-2399, United States

Location

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229-3993, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113-1100, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05405, United States

Location

University of Virginia Cancer Center at UV Health System

Charlottesville, Virginia, 22908, United States

Location

INOVA Fairfax Hospital

Fairfax, Virginia, 22031, United States

Location

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507-1971, United States

Location

Edwards Comprehensive Cancer Center at Cabell Huntington Hospital

Huntington, West Virginia, 25701, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Westmead Institute for Cancer Research at Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 1Z2, Canada

Location

Children's & Women's Hospital of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Children's Hospital of Western Ontario

London, Ontario, N6A 4G5, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital at McGill University Health Center

Montreal, Quebec, H3H 1P3, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre at the University of Saskatchewan

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, G1V 4G2, Canada

Location

Swiss Pediatric Oncology Group Geneva

Geneva, 1205, Switzerland

Location

Related Publications (2)

• Widemann BC, Balis FM, Shalabi A, Boron M, O'Brien M, Cole DE, Jayaprakash N, Ivy P, Castle V, Muraszko K, Moertel CL, Trueworthy R, Hermann RC, Moussa A, Hinton S, Reaman G, Poplack D, Adamson PC. Treatment of accidental intrathecal methotrexate overdose with intrathecal carboxypeptidase G2. J Natl Cancer Inst. 2004 Oct 20;96(20):1557-9. doi: 10.1093/jnci/djh270.

  PMID: 15494606 RESULT

• Widemann BC, Balis FM, Shalabi A, et al.: Carboxypeptidase-G2 (CPDG2) treatment of accidental intrathecal (IT) methotrexate (MTX) overdose. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-490, 2002.

  RESULT

MeSH Terms

Conditions

Neurotoxicity Syndromes

Interventions

glucarpidase

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Brigitte C. Widemann, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: November 1, 1993
• Primary Completion: April 1, 2007
• Last Updated: April 30, 2015

Record last verified: 2007-04

Locations

CH (1); AU (2); US (88); CA (12)