AzTrials
AzTrials

Brain and Central Nervous System TumorsPhase 2NCT00019422

Lobradimil and Carboplatin in Treating Children With Brain Tumors

A Phase 2 study testing carboplatin and lobradimil in people with Brain and Central Nervous System Tumors, run by National Cancer Institute (NCI) at 236 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
carboplatin and lobradimil
How many people
Not given
Where
236 sitesin 7 countries
Study dates
Mar 1998to Apr 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

236 sites in 7 countries.

236 sites in 7 countries

United States207 sites

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131

  • Texas Tech University Health Sciences Center School of Medicine

    Amarillo, Texas, 79106

  • Mott Children's Hospital

    Ann Arbor, Michigan, 48109-0914

  • Mission Saint Joseph's Health System

    Asheville, North Carolina, 28801

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Children's Healthcare of Atlanta - Scottish Rite

    Atlanta, Georgia, 30342

  • Medical College of Georgia Comprehensive Cancer Center

    Augusta, Georgia, 30912-4000

  • Children's Hospital of Austin

    Austin, Texas, 78701

  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201-1595

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21225

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35233

  • Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Floating Hospital for Children

    Boston, Massachusetts, 02111

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Brooklyn Hospital Center

    Brooklyn, New York, 11201

  • State University of New York Health Science Center at Brooklyn College of Medicine

    Brooklyn, New York, 11203

  • Brookdale University Hospital and Medical Center

    Brooklyn, New York, 11212

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • West Virginia University - Charleston

    Charleston, West Virginia, 25302

  • Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Healthcare

    Charlotte, North Carolina, 28233-3549

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60601

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Children's Memorial Hospital - Chicago

    Chicago, Illinois, 60614

  • Children's Hospital Medical Center - Cincinnati

    Cincinnati, Ohio, 45229-3039

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Palmetto Health South Carolina Cancer Center

    Columbia, South Carolina, 29203

  • Children's Hospital of Columbus

    Columbus, Ohio, 43205-2696

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-1320

  • Children's Medical Center - Dayton

    Dayton, Ohio, 45404

  • Children's Hospital of Denver

    Denver, Colorado, 80218-1088

  • Childhood Hematology/Oncology Associates

    Denver, Colorado, 80218

  • Presbyterian-St Luke's Medical Center

    Denver, Colorado, 80218

  • Raymond Blank Memorial Hospital for Children

    Des Moines, Iowa, 50308

  • John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Southern California Permanente Medical Group

    Downey, California, 90242

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • St. Mary's/Duluth Clinic Cancer Center

    Duluth, Minnesota, 55805-1983

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Michigan State University

    East Lansing, Michigan, 48824

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042-3300

  • Dakota Cancer Institute

    Fargo, North Dakota, 58103-4940

  • University of Connecticut Health Center

    Farmington, Connecticut, 06360-7106

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

  • Shands Hospital and Clinics, University of Florida

    Gainesville, Florida, 32610-100277

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0361

  • Spectrum Health and DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54301

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-9070

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27858-4354

  • Children's Hospital of Greenville Hospital System

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Joe DiMaggio Children's Hospital at Memorial

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Cabell-Huntington Hospital, Inc

    Huntington, West Virginia, 25701

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • St. Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242-1009

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • East Tennessee State University Cancer Center at JCMC

    Johnson City, Tennessee, 37604

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • East Tennessee Children's Hospital

    Knoxville, Tennessee, 37901

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • San Antonio Military Pediatric Cancer and Blood Disorders Center

    Lackland Air Force Base, Texas, 78236-5300

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109-2306

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756-0002

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0284

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Jonathan Jaques Children's Cancer Center

    Long Beach, California, 90801-1428

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027-0700

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Kosair Children's Hospital

    Louisville, Kentucky, 40202-3830

  • Covenant Children's Hospital

    Lubbock, Texas, 79410

  • Medical Center of Central Georgia

    Macon, Georgia, 31201

  • Children's Hospital Central California

    Madera, California, 93638-8762

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792-0001

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449-5772

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105-2794

  • University of Miami-Jackson Memorial Hospital

    Miami, Florida, 33136

  • Miami Children's Hospital

    Miami, Florida, 33155-4069

  • Baptist Hospital of Miami

    Miami, Florida, 33176-2197

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • Children's Hospitals and Clinics - Minneapolis

    Minneapolis, Minnesota, 55404

  • University of South Alabama Medical Center

    Mobile, Alabama, 36604

  • West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9300

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8028

  • Schneider Children's Hospital

    New Hyde Park, New York, 11042

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Children's Hospital of New Orleans

    New Orleans, Louisiana, 70118

  • Ochsner Clinic

    New Orleans, Louisiana, 70121

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York, 10021-4885

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia Presbyterian Hospital

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112-2094

  • Children's Hospital of the King's Daughters

    Norfolk, Virginia, 23507

  • Hope Children's Hospital

    Oak Lawn, Illinois, 60453

  • Children's Hospital of Oakland

    Oakland, California, 94609-1809

  • Children's Hospital of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital of Omaha

    Omaha, Nebraska, 68114

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-2168

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32803

  • Nemours Children's Clinic-Orlando

    Orlando, Florida, 32806

  • Lucile Packard Children's Hospital at Stanford

    Palo Alto, California, 94304

  • Lutheran General Hospital

    Park Ridge, Illinois, 60068-1174

  • St. Joseph's Hospital and Medical Center

    Paterson, New Jersey, 07503

  • Sacred Heart Children's Hospital

    Pensacola, Florida, 32504

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61637

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134-1095

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016-7710

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Doernbecher Children's Hospital

    Portland, Oregon, 97201-3098

  • Legacy Emanuel Hospital and Health Center

    Portland, Oregon, 97227

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-5100

  • Rhode Island Hospital

    Providence, Rhode Island, 02818

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Carilion Medical Center for Children

    Roanoke, Virginia, 24013

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • James P. Wilmot Cancer Center

    Rochester, New York, 14642

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073-6769

  • Sutter Cancer Center

    Sacramento, California, 95816

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Children's Hospitals and Clinics of Minnesota

    Saint Paul, Minnesota, 55102

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78207

  • Methodist Health Care System

    San Antonio, Texas, 78229-3902

  • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

    San Diego, California, 92120

  • Children's Hospital San Diego

    San Diego, California, 92123-4282

  • Kaiser Permanente Medical Center - San Francisco Geary Campus

    San Francisco, California, 94115

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143-0128

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93102

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051-5386

  • Memorial Health University Medical Center, Inc.

    Savannah, Georgia, 31403-3089

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • Group Health Cooperative

    Seattle, Washington, 98112

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105-1080

  • Sioux Valley Hospital

    Sioux Falls, South Dakota, 57117

  • Deaconess Medical Center

    Spokane, Washington, 99210-0248

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794-9658

  • Baystate Medical Center

    Springfield, Massachusetts, 01107

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York, 11790-7775

  • Atlantic Health System

    Summit, New Jersey, 07901

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Mary Bridge Children's Health Center

    Tacoma, Washington, 98415-0299

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-5000

  • Tampa Children's Hospital

    Tampa, Florida, 33677-4227

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Albert Einstein Clinical Cancer Center

    The Bronx, New York, 10461

  • Toledo Children's Hospital

    Toledo, Ohio, 43601

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • Natalie Warren Bryant Cancer Center

    Tulsa, Oklahoma, 74136

  • New York Medical College

    Valhalla, New York, 10595

  • Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

  • Children's National Medical Center

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

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • St. Mary's Hospital

    West Palm Beach, Florida, 33407

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Alfred I. Dupont Institute

    Wilmington, Delaware, 19899

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1081

  • University of Massachusetts Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655

  • Forum Health-Tod Childrens Hospital

    Youngstown, Ohio, 44501

Other trials in United States

Canada16 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T2T 5C7

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • IWK Health Centre

    Halifax, Nova Scotia, B3J 3G9

  • Children's Hospital

    Hamilton, Ontario, L8N 3Z5

  • Children's Hospital of Western Ontario

    London, Ontario, N6C 2V5

  • McGill University Health Center - Montreal Children's Hospital

    Montreal, Quebec, H3H 1P3

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Laval University Medical Center

    Sainte-Foy, Quebec, G1V 4G2

  • Centre Hospitalier de L'Universite Laval

    Sainte-Foy, Quebec, GIV 4G2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Janeway Children's Health and Rehabilitation Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3V4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia6 sites

  • Royal Children's Hospital

    Brisbane, Queensland, 4029

  • Women's and Children's Hospital

    North Adelaide, South Australia, 5006

  • Royal Children's Hospital

    Parkville, Victoria, 3052

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6001

  • Sydney Children's Hospital

    Randwick, New South Wales, 2031

  • Children's Hospital at Westmead

    Westmead, New South Wales, 2145

Other trials in Australia

Switzerland3 sites

  • Swiss Pediatric Oncology Group Bern

    Bern, CH 3010

  • Swiss Pediatric Oncology Group Geneva

    Geneva, CH 1211

  • Swiss Pediatric Oncology Group Lausanne

    Lausanne, CH 1011

Other trials in Switzerland

Puerto Rico2 sites

  • University of Puerto Rico School of Medicine Medical Sciences Campus

    San Juan, 00936-5067

  • San Jorge Childrens Hospital

    Santurce, 00912

Other trials in Puerto Rico

Netherlands1 site

  • Academisch Ziekenhuis Groningen

    Groningen, 9700 RB

Other trials in Netherlands

New Zealand1 site

  • Starship Children's Hospital

    Auckland

Other trials in New Zealand

About this study

Official title: A Phase II Trial of Intravenous Cereport (RMP-7) and Carboplatin in Childhood Brain Tumors

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.

Read the 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.

Being tested
carboplatin, lobradimil
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
Medical subject headings
Central Nervous System Neoplasms, Astrocytoma, Medulloblastoma, Optic Nerve Glioma, Familial ependymoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 1998
  3. Study completionApr 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00019422
Sponsor's protocol ID
CDR0000066169
Other IDs
NCI-98-C-0074H, CCG-09716, ALK-01-041, NCI-T98-0011, COG-C09716
Status last verified
Apr 2003
First submitted
11 Jul 2001
Last updated
16 Aug 2013
Results posted
No

Publications

  • 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.

    PubMed 11710627

  • 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.

    PubMed 16408203

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin and lobradimil in people with Brain and Central Nervous System Tumors, run by National Cancer Institute (NCI) at 236 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 236 sites in United States, Canada, Australia, Switzerland, Puerto Rico and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00019422, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2013.

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