Lobradimil and Carboplatin in Treating Children With Brain Tumors
NCT ID: NCT00019422
Last Updated: 2013-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1998-03-31
2003-04-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of carboplatin and lobradimil in treating children with brain tumors that have not responded to previous treatment.
Detailed Description
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* Determine the objective response rate in patients with recurrent or refractory childhood brain tumors treated with lobradimil and carboplatin.
* Determine the time to progression in patients treated with this regimen.
* Assess the toxicity of this regimen in this patient population.
* Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients are stratified according to histology (high-grade glioma vs low-grade glioma vs brainstem or visual pathway glioma vs medulloblastoma/primitive neuroectodermal tumor vs ependymoma). (Brainstem glioma stratum closed to accrual as of 12/21/2000.) (High-grade glioma stratum closed to accrual as of 01/08/2002.)
Patients receive carboplatin IV over 15 minutes and lobradimil IV over 10 minutes on days 1 and 2. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 12, patients may receive additional courses at the discretion of the institutional investigator.
Quality of life is assessed at baseline and then every 3 courses.
Patients are followed every 3 months for 1 year or until evidence of disease progression or initiation of a new therapy.
PROJECTED ACCRUAL: A maximum of 146 patients will be accrued for this study within 2-4 years.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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carboplatin
lobradimil
Eligibility Criteria
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Inclusion Criteria
* Diffuse meningeal involvement not considered measurable if it is the only site of disease
* Disease must not be limited to the meninges
* No metastases outside of the CNS
PATIENT CHARACTERISTICS:
Age:
* 21 and under at diagnosis
Performance status:
* ECOG 0-2
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Absolute granulocyte count at least 1,000/mm\^3
* Hemoglobin at least 8.0 g/dL (transfusion allowed)
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGPT no greater than 2.5 times ULN
* No significant hepatic illness
Renal:
* Creatinine within limits as defined below by age:
* Age 5 and under: less than 1.2 mg/dL
* Age 6 to 10: less than 1.5 mg/dL
* Age 11 to 15: less than 1.8 mg/dL
* Age 16 and over: less than 2.4 mg/dL
Cardiovascular:
* No significant cardiac illness
Pulmonary:
* No significant pulmonary illness
Other:
* No significant systemic illness or organ dysfunction that would preclude study
* No allergic reaction to platinum-containing compounds
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 72 hours since filgrastim (G-CSF)
* No concurrent biologic therapy for brain tumor
Chemotherapy:
* See Disease Characteristics
* No prior carboplatin or lobradimil
* No more than 1 prior chemotherapy regimen for high-grade glioma, low-grade glioma, or ependymoma
* No more than 2 prior chemotherapy regimens for medulloblastoma/PNET
* At least 4 weeks since prior nitrosoureas (2 weeks if also received stem cell/bone marrow rescue)
* At least 2 weeks since any other prior myelosuppressive chemotherapy and recovered
* No other concurrent chemotherapy for brain tumor
Endocrine therapy:
* Concurrent corticosteroids for management of tumor-related edema allowed
Radiotherapy:
* See Disease Characteristics
* At least 6 weeks since prior radiotherapy to measurable disease and recovered
* No concurrent radiotherapy for brain tumor
Surgery:
* No concurrent surgery except for ventriculo-peritoneal shunt placement or revision
Other:
* At least 24 hours since prior vasodilating agents, angiotensin-converting enzyme inhibitors, calcium channel blockers, or beta-blockers
21 Years
ALL
No
Sponsors
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Children's Oncology Group
NETWORK
National Cancer Institute (NCI)
NIH
Principal Investigators
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Katherine Warren, MD
Role: STUDY_CHAIR
National Cancer Institute (NCI)
Regina Jakacki, MD
Role: STUDY_CHAIR
University of Pittsburgh
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
University of South Alabama Medical Center
Mobile, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Children's Hospital of Oakland
Oakland, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States
Sutter Cancer Center
Sacramento, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States
Children's Hospital San Diego
San Diego, California, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
Children's Hospital of Denver
Denver, Colorado, United States
Childhood Hematology/Oncology Associates
Denver, Colorado, United States
Presbyterian-St Luke's Medical Center
Denver, Colorado, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Alfred I. Dupont Institute
Wilmington, Delaware, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States
Joe DiMaggio Children's Hospital at Memorial
Hollywood, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
University of Miami-Jackson Memorial Hospital
Miami, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Nemours Children's Clinic-Orlando
Orlando, Florida, United States
Sacred Heart Children's Hospital
Pensacola, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Tampa Children's Hospital
Tampa, Florida, United States
St. Mary's Hospital
West Palm Beach, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, United States
Medical College of Georgia Comprehensive Cancer Center
Augusta, Georgia, United States
Medical Center of Central Georgia
Macon, Georgia, United States
Memorial Health University Medical Center, Inc.
Savannah, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Mountain States Tumor Institute
Boise, Idaho, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States
Hope Children's Hospital
Oak Lawn, Illinois, United States
Lutheran General Hospital
Park Ridge, Illinois, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
Raymond Blank Memorial Hospital for Children
Des Moines, Iowa, United States
John Stoddard Cancer Center
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Wesley Medical Center
Wichita, Kansas, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Maine Children's Cancer Program
Scarborough, Maine, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
Floating Hospital for Children
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Spectrum Health and DeVos Children's Hospital
Grand Rapids, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
CCOP - Beaumont
Royal Oak, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
St. Mary's/Duluth Clinic Cancer Center
Duluth, Minnesota, United States
Children's Hospitals and Clinics - Minneapolis
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Children's Hospital of Omaha
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States
Atlantic Health System
Summit, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Cancer Center of Albany Medical Center
Albany, New York, United States
Brooklyn Hospital Center
Brooklyn, New York, United States
State University of New York Health Science Center at Brooklyn College of Medicine
Brooklyn, New York, United States
Brookdale University Hospital and Medical Center
Brooklyn, New York, United States
Maimonides Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Schneider Children's Hospital
New Hyde Park, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia Presbyterian Hospital
New York, New York, United States
James P. Wilmot Cancer Center
Rochester, New York, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Albert Einstein Clinical Cancer Center
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Mission Saint Joseph's Health System
Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Presbyterian Healthcare
Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Dakota Cancer Institute
Fargo, North Dakota, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Children's Hospital of Columbus
Columbus, Ohio, United States
Children's Medical Center - Dayton
Dayton, Ohio, United States
Toledo Children's Hospital
Toledo, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Forum Health-Tod Childrens Hospital
Youngstown, Ohio, United States
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States
Doernbecher Children's Hospital
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Sioux Valley Hospital
Sioux Falls, South Dakota, United States
East Tennessee State University Cancer Center at JCMC
Johnson City, Tennessee, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States
Children's Hospital of Austin
Austin, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States
Covenant Children's Hospital
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Methodist Health Care System
San Antonio, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Vermont Cancer Center
Burlington, Vermont, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
Carilion Medical Center for Children
Roanoke, Virginia, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Group Health Cooperative
Seattle, Washington, United States
Deaconess Medical Center
Spokane, Washington, United States
Mary Bridge Children's Health Center
Tacoma, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
West Virginia University - Charleston
Charleston, West Virginia, United States
Cabell-Huntington Hospital, Inc
Huntington, West Virginia, United States
West Virginia University Hospitals
Morgantown, West Virginia, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Sydney Children's Hospital
Randwick, New South Wales, Australia
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Royal Children's Hospital
Brisbane, Queensland, Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Alberta Children's Hospital
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
Children's Hospital
Hamilton, Ontario, Canada
Children's Hospital of Western Ontario
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Laval University Medical Center
Sainte-Foy, Quebec, Canada
Centre Hospitalier de L'Universite Laval
Sainte-Foy, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
Starship Children's Hospital
Auckland, , New Zealand
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , Puerto Rico
San Jorge Childrens Hospital
Santurce, , Puerto Rico
Swiss Pediatric Oncology Group Bern
Bern, , Switzerland
Swiss Pediatric Oncology Group Geneva
Geneva, , Switzerland
Swiss Pediatric Oncology Group Lausanne
Lausanne, , Switzerland
Countries
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References
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Warren KE, Patel MC, Aikin AA, Widemann B, Libucha M, Adamson PC, Neuwirth R, Benziger D, O'Toole T, Ford K, Patronas N, Packer RJ, Balis FM. Phase I trial of lobradimil (RMP-7) and carboplatin in children with brain tumors. Cancer Chemother Pharmacol. 2001 Oct;48(4):275-82. doi: 10.1007/s002800100356.
Warren KE, Patel MC, Adamson PC, et al.: Phase I trial of RMP-7 and carboplatin in pediatric patients with brain tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A-764, 1998.
Warren K, Jakacki R, Widemann B, Aikin A, Libucha M, Packer R, Vezina G, Reaman G, Shaw D, Krailo M, Osborne C, Cehelsky J, Caldwell D, Stanwood J, Steinberg SM, Balis FM. Phase II trial of intravenous lobradimil and carboplatin in childhood brain tumors: a report from the Children's Oncology Group. Cancer Chemother Pharmacol. 2006 Sep;58(3):343-7. doi: 10.1007/s00280-005-0172-7. Epub 2006 Jan 12.
Other Identifiers
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NCI-98-C-0074H
Identifier Type: -
Identifier Source: secondary_id
CCG-09716
Identifier Type: -
Identifier Source: secondary_id
ALK-01-041
Identifier Type: -
Identifier Source: secondary_id
NCI-T98-0011
Identifier Type: -
Identifier Source: secondary_id
COG-C09716
Identifier Type: -
Identifier Source: secondary_id
CDR0000066169
Identifier Type: -
Identifier Source: org_study_id
NCT00001690
Identifier Type: -
Identifier Source: nct_alias