Clinical trial NCT00019422: Lobradimil and Carboplatin in Treating Children With Brain Tumors
Official title: A Phase II Trial of Intravenous Cereport (RMP-7) and Carboplatin in Childhood Brain Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: childhood low-grade cerebral astrocytoma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
untreated childhood visual pathway and hypothalamic glioma
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood ependymoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: Children's Oncology Group
First posted: 2003-01-27
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed childhood brain tumor that is recurrent or refractory or for which no standard chemotherapy exists

  * High-grade glioma (anaplastic astrocytoma or glioblastoma multiforme) (High-grade glioma stratum closed to accrual as of 01/08/2002)
  * Low-grade glioma
  * Medulloblastoma/primitive neuroectodermal tumor (PNET)
  * Ependymoma
  * Brainstem tumor or visual pathway glioma (with radiographic evidence only) (Brainstem glioma stratum closed to accrual as of 12/21/2000)
* Evidence of recurrent or progressive disease after front-line therapy documented as an increase in tumor size or appearance of new lesion(s) on MRI
* Patients who did not previously receive radiotherapy as front-line therapy are eligible at time of second recurrence if the first recurrence was treated with radiotherapy only
* Measurable disease in at least 2 dimensions by MRI

  * 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Center
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Downey
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: La Jolla
country: United States
facility: Rebecca and John Moores UCSD Cancer Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Long Beach
country: United States
facility: Jonathan Jaques Children's Cancer Center
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: Madera
country: United States
facility: Children's Hospital Central California
state: California
city: Oakland
country: United States
facility: Children's Hospital of Oakland
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital at Stanford
state: California
city: Sacramento
country: United States
facility: Sutter Cancer Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
state: California
city: San Diego
country: United States
facility: Children's Hospital San Diego
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center - San Francisco Geary Campus
state: California
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Medical Center - Santa Clara
state: California
city: Travis Air Force Base
country: United States
facility: David Grant Medical Center
state: California
city: Denver
country: United States
facility: Children's Hospital of Denver
state: Colorado
city: Denver
country: United States
facility: Childhood Hematology/Oncology Associates
state: Colorado
city: Denver
country: United States
facility: Presbyterian-St Luke's Medical Center
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: New Haven
country: United States
facility: Yale Comprehensive Cancer Center
state: Connecticut
city: Wilmington
country: United States
facility: Alfred I. Dupont Institute
state: Delaware
city: Washington
country: United States
facility: Lombardi Cancer Center
state: District of Columbia
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Broward General Medical Center
state: Florida
city: Fort Myers
country: United States
facility: Children's Hospital of Southwest Florida
state: Florida
city: Gainesville
country: United States
facility: Shands Hospital and Clinics, University of Florida
state: Florida
city: Hollywood
country: United States
facility: Joe DiMaggio Children's Hospital at Memorial
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami-Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Clinic-Orlando
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Children's Hospital
state: Florida
city: St. Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa Children's Hospital
state: Florida
city: West Palm Beach
country: United States
facility: St. Mary's Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital - Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Scottish Rite
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia Comprehensive Cancer Center
state: Georgia
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center, Inc.
state: Georgia
city: Honolulu
country: United States
facility: Cancer Research Center of Hawaii
state: Hawaii
city: Honolulu
country: United States
facility: MBCCOP - Hawaii
state: Hawaii
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Boise
country: United States
facility: Mountain States Tumor Institute
state: Idaho
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Chicago
country: United States
facility: Rush-Presbyterian-St. Luke's Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: Children's Memorial Hospital - Chicago
state: Illinois
city: Oak Lawn
country: United States
facility: Hope Children's Hospital
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran General Hospital
state: Illinois
city: Peoria
country: United States
facility: Saint Jude Midwest Affiliate
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital and Health Care Center
state: Indiana
city: Des Moines
country: United States
facility: Raymond Blank Memorial Hospital for Children
state: Iowa
city: Des Moines
country: United States
facility: John Stoddard Cancer Center
state: Iowa
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center
state: Iowa
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Lexington
country: United States
facility: Albert B. Chandler Medical Center, University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: New Orleans
country: United States
facility: Children's Hospital of New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Scarborough
country: United States
facility: Maine Children's Cancer Program
state: Maine
city: Baltimore
country: United States
facility: Marlene and Stewart Greenebaum Cancer Center, University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
state: Maryland
city: Boston
country: United States
facility: Floating Hospital for Children
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center - University Campus
state: Massachusetts
city: Ann Arbor
country: United States
facility: Mott Children's Hospital
state: Michigan
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health and DeVos Children's Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
city: Royal Oak
country: United States
facility: CCOP - Beaumont
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Duluth
country: United States
facility: St. Mary's/Duluth Clinic Cancer Center
state: Minnesota
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics - Minneapolis
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Paul
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Cardinal Glennon Children's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Omaha
country: United States
facility: Children's Hospital of Omaha
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Sunrise Hospital and Medical Center
state: Nevada
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Paterson
country: United States
facility: St. Joseph's Hospital and Medical Center
state: New Jersey
city: Summit
country: United States
facility: Atlantic Health System
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Research and Treatment Center
state: New Mexico
city: Albany
country: United States
facility: Cancer Center of Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Albert Einstein Clinical Cancer Center
state: New York
city: Brooklyn
country: United States
facility: Brooklyn Hospital Center
state: New York
city: Brooklyn
country: United States
facility: State University of New York Health Science Center at Brooklyn College of Medicine
state: New York
city: Brooklyn
country: United States
facility: Brookdale University Hospital and Medical Center
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Schneider Children's Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Cornell Campus
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center
state: New York
city: Stony Brook
country: United States
facility: State University of New York Health Sciences Center - Stony Brook
state: New York
city: Syracuse
country: United States
facility: State University of New York - Upstate Medical University
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Asheville
country: United States
facility: Mission Saint Joseph's Health System
state: North Carolina
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Healthcare
state: North Carolina
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University School of Medicine
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Fargo
country: United States
facility: Dakota Cancer Institute
state: North Dakota
city: Akron
country: United States
facility: Children's Hospital Medical Center of Akron
state: Ohio
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center - Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Children's Hospital of Columbus
state: Ohio
city: Dayton
country: United States
facility: Children's Medical Center - Dayton
state: Ohio
city: Toledo
country: United States
facility: Toledo Children's Hospital
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Mercy Medical Center
state: Ohio
city: Youngstown
country: United States
facility: Forum Health-Tod Childrens Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Children's Hospital of Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: CCOP - Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Natalie Warren Bryant Cancer Center
state: Oklahoma
city: Portland
country: United States
facility: Doernbecher Children's Hospital
state: Oregon
city: Portland
country: United States
facility: Legacy Emanuel Hospital and Health Center
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Palmetto Health South Carolina Cancer Center
state: South Carolina
city: Greenville
country: United States
facility: Children's Hospital of Greenville Hospital System
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Sioux Falls
country: United States
facility: Sioux Valley Hospital
state: South Dakota
city: Johnson City
country: United States
facility: East Tennessee State University Cancer Center at JCMC
state: Tennessee
city: Knoxville
country: United States
facility: East Tennessee Children's Hospital
state: Tennessee
city: Memphis
country: United States
facility: Saint Jude Children's Research Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Amarillo
country: United States
facility: Texas Tech University Health Sciences Center School of Medicine
state: Texas
city: Austin
country: United States
facility: Children's Hospital of Austin
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Dallas
country: United States
facility: Simmons Cancer Center - Dallas
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center - Fort Worth
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Lackland Air Force Base
country: United States
facility: San Antonio Military Pediatric Cancer and Blood Disorders Center
state: Texas
city: Lubbock
country: United States
facility: Covenant Children's Hospital
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: San Antonio
country: United States
facility: Methodist Health Care System
state: Texas
city: Temple
country: United States
facility: Scott and White Memorial Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Burlington
country: United States
facility: Vermont Cancer Center
state: Vermont
city: Charlottesville
country: United States
facility: Cancer Center at the University of Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
city: Portsmouth
country: United States
facility: Naval Medical Center, Portsmouth
state: Virginia
city: Richmond
country: United States
facility: Massey Cancer Center
state: Virginia
city: Roanoke
country: United States
facility: Carilion Medical Center for Children
state: Virginia
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center - Seattle
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Seattle
country: United States
facility: Group Health Cooperative
state: Washington
city: Spokane
country: United States
facility: Deaconess Medical Center
state: Washington
city: Tacoma
country: United States
facility: Mary Bridge Children's Health Center
state: Washington
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
city: Charleston
country: United States
facility: West Virginia University - Charleston
state: West Virginia
city: Huntington
country: United States
facility: Cabell-Huntington Hospital, Inc
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospitals
state: West Virginia
city: Green Bay
country: United States
facility: Bellin Memorial Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: CCOP - St. Vincent Hospital Cancer Center, Green Bay
state: Wisconsin
city: Green Bay
country: United States
facility: St. Vincent Hospital
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Midwest Children's Cancer Center
state: Wisconsin
city: Randwick
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Children's Hospital at Westmead
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Children's Hospital
state: Queensland
city: North Adelaide
country: Australia
facility: Women's and Children's Hospital
state: South Australia
city: Parkville
country: Australia
facility: Royal Children's Hospital
state: Victoria
city: Perth
country: Australia
facility: Princess Margaret Hospital for Children
state: Western Australia
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: St. John's
country: Canada
facility: Janeway Children's Health and Rehabilitation Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Children's Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital of Western Ontario
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center - Montreal Children's Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hopital Sainte Justine
state: Quebec
city: Sainte Foy
country: Canada
facility: Centre Hospitalier de L'Universite Laval
state: Quebec
city: Sainte-Foy
country: Canada
facility: Laval University Medical Center
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Groningen
country: Netherlands
facility: Academisch Ziekenhuis Groningen
city: Auckland
country: New Zealand
facility: Starship Children's Hospital
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico School of Medicine Medical Sciences Campus
city: Santurce
country: Puerto Rico
facility: San Jorge Childrens Hospital
city: Bern
country: Switzerland
facility: Swiss Pediatric Oncology Group Bern
city: Geneva
country: Switzerland
facility: Swiss Pediatric Oncology Group Geneva
city: Lausanne
country: Switzerland
facility: Swiss Pediatric Oncology Group Lausanne
Study officials:
affiliation: National Cancer Institute (NCI)
name: Katherine Warren, MD
role: STUDY_CHAIR
affiliation: University of Pittsburgh
name: Regina Jakacki, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.