Lobradimil and Carboplatin in Treating Children With Brain Tumors
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00019422
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Lobradimil may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.
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
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (235)
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Floating Hospital for Children
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Sioux Valley Hospital
🇺🇸Sioux Falls, South Dakota, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Children's Hospital of Western Ontario
🇨🇦London, Ontario, Canada
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Group Health Cooperative
🇺🇸Seattle, Washington, United States
Sunrise Hospital and Medical Center
🇺🇸Las Vegas, Nevada, United States
Children's Hospital Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, 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
St. Vincent Hospital and Health Care Center
🇺🇸Indianapolis, Indiana, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
🇺🇸San Diego, California, United States
Children's Hospitals and Clinics - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, 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
Kaiser Permanente Medical Center - San Francisco Geary Campus
🇺🇸San Francisco, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
St. Mary's/Duluth Clinic Cancer Center
🇺🇸Duluth, Minnesota, United States
Children's Hospitals and Clinics of Minnesota
🇺🇸Saint Paul, Minnesota, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
New York Medical College
🇺🇸Valhalla, New York, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, 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
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
Doernbecher Children's Hospital
🇺🇸Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center
🇺🇸Portland, Oregon, United States
Tampa Children's Hospital
🇺🇸Tampa, Florida, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Children's Hospital of Omaha
🇺🇸Omaha, Nebraska, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Jonathan Jaques Children's Cancer Center
🇺🇸Long Beach, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
Kaiser Permanente Medical Center - Santa Clara
🇺🇸Santa Clara, California, United States
Shands Hospital and Clinics, University of Florida
🇺🇸Gainesville, Florida, United States
Saint Jude Midwest Affiliate
🇺🇸Peoria, Illinois, United States
Memorial Health University Medical Center, Inc.
🇺🇸Savannah, Georgia, United States
Joe DiMaggio Children's Hospital at Memorial
🇺🇸Hollywood, Florida, United States
Children's Hospital San Diego
🇺🇸San Diego, California, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Alfred I. Dupont Institute
🇺🇸Wilmington, Delaware, United States
Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Medical Center of Central Georgia
🇺🇸Macon, Georgia, United States
Children's Healthcare of Atlanta - Scottish Rite
🇺🇸Atlanta, Georgia, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, 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
University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Schneider Children's Hospital
🇺🇸New Hyde Park, New York, United States
Children's Hospital of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Presbyterian Healthcare
🇺🇸Charlotte, North Carolina, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Mission Saint Joseph's Health System
🇺🇸Asheville, North Carolina, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Children's Hospital of Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
Children's Hospital of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Forum Health-Tod Childrens Hospital
🇺🇸Youngstown, Ohio, United States
Dakota Cancer Institute
🇺🇸Fargo, North Dakota, United States
Natalie Warren Bryant Cancer Center
🇺🇸Tulsa, Oklahoma, United States
Covenant Children's Hospital
🇺🇸Lubbock, Texas, United States
Texas Tech University Health Sciences Center School of Medicine
🇺🇸Amarillo, Texas, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Saint Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
Centre Hospitalier de L'Universite Laval
🇨🇦Sainte Foy, Quebec, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
Swiss Pediatric Oncology Group Bern
🇨🇭Bern, Switzerland
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
West Virginia University - Charleston
🇺🇸Charleston, West Virginia, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Scott and White Memorial Hospital
🇺🇸Temple, Texas, United States
Cabell-Huntington Hospital, Inc
🇺🇸Huntington, West Virginia, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Women's and Children's Hospital
🇦🇺North Adelaide, South Australia, Australia
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
San Jorge Childrens Hospital
🇵🇷Santurce, Puerto Rico
Swiss Pediatric Oncology Group Geneva
🇨🇭Geneva, Switzerland
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Raymond Blank Memorial Hospital for Children
🇺🇸Des Moines, Iowa, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of South Alabama Medical Center
🇺🇸Mobile, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Children's Hospital of Oakland
🇺🇸Oakland, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Children's National Medical Center
🇺🇸Washington, 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
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
St. Mary's Hospital
🇺🇸West Palm Beach, Florida, United States
Sacred Heart Children's Hospital
🇺🇸Pensacola, Florida, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Medical College of Georgia Comprehensive Cancer Center
🇺🇸Augusta, Georgia, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
Hope Children's Hospital
🇺🇸Oak Lawn, Illinois, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Michigan State University
🇺🇸East Lansing, 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
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, 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
Albert Einstein Clinical Cancer Center
🇺🇸Bronx, New York, 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
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
James P. Wilmot Cancer Center
🇺🇸Rochester, New York, United States
Columbia Presbyterian Hospital
🇺🇸New York, New York, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
Toledo Children's Hospital
🇺🇸Toledo, Ohio, 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
Palmetto Health South Carolina Cancer Center
🇺🇸Columbia, South Carolina, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
East Tennessee State University Cancer Center at JCMC
🇺🇸Johnson City, Tennessee, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
🇺🇸Lackland Air Force Base, Texas, United States
Carilion Medical Center for Children
🇺🇸Roanoke, Virginia, United States
Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Mary Bridge Children's Health Center
🇺🇸Tacoma, Washington, United States
Bellin Memorial Hospital
🇺🇸Green Bay, Wisconsin, United States
West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Sydney Children's Hospital
🇦🇺Randwick, New South Wales, Australia
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Laval University Medical Center
🇨🇦Sainte-Foy, Quebec, Canada
Children's Hospital
🇨🇦Hamilton, Ontario, Canada
McGill University Health Center - Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Starship Children's Hospital
🇳🇿Auckland, New Zealand
Swiss Pediatric Oncology Group Lausanne
🇨🇭Lausanne, Switzerland
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Nemours Children's Clinic-Orlando
🇺🇸Orlando, Florida, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
Children's Hospital of Austin
🇺🇸Austin, Texas, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Janeway Children's Health and Rehabilitation Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States