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Spots Global Cancer Trial Database for O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors

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Trial Identification

Brief Title: O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors

Official Title: A Trial of 06-BG and BCNU in Children With CNS Tumors

Study ID: NCT00003765

Study Description

Brief Summary: Phase I trial to study the effectiveness of O6-benzylguanine and carmustine in treating children who have refractory CNS tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Detailed Description: OBJECTIVES: I. Determine the maximum tolerated dose and the dose limiting toxicity of carmustine administered after O6-benzylguanine in children with refractory primary CNS tumors. II. Determine a safe and tolerable dose of carmustine administered after O6-benzylguanine to be used in phase II studies. III. Determine the pharmacokinetics of O6-benzylguanine and its metabolite, O6-benzyl-8-oxoguanine, in these patients. IV. Seek preliminary evidence of antitumor activity of this regimen in these patients. V. Evaluate the acute and chronic toxicities, and describe cumulative toxicity, in patients treated with multiple courses of this regimen. OUTLINE: This is a dose escalation study of carmustine. Patients receive O6-benzylguanine IV over 1 hour, then, 1 hour later, carmustine IV is administered over 1 hour. Treatment is repeated every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of carmustine until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose level at which fewer than 2 of 6 patients experience dose limiting toxicity (DLT). If myelosuppression is the DLT, stratum 1 is closed and patients are accrued to stratum 2. If neutropenia is the DLT in stratum 2, patients receive filgrastim (G-CSF) subcutaneously beginning on day 2 and continuing until blood counts recover. Patients are followed every 6 months for 4 years, then annually thereafter.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

University of California San Diego Cancer Center, La Jolla, California, United States

Children's Hospital Los Angeles, Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

City of Hope National Medical Center, Los Angeles, California, United States

Children's Hospital of Orange County, Orange, California, United States

UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States

Stanford University Medical Center, Stanford, California, United States

Children's National Medical Center, Washington, District of Columbia, United States

University of Florida Health Science Center, Gainesville, Florida, United States

Emory University Hospital - Atlanta, Atlanta, Georgia, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States

Children's Memorial Hospital, Chicago, Chicago, Illinois, United States

Indiana University Cancer Center, Indianapolis, Indiana, United States

University of Kansas Medical Center, Kansas City, Kansas, United States

Johns Hopkins Oncology Center, Baltimore, Maryland, United States

Boston Floating Hospital Infants and Children, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Children's Hospital of Michigan, Detroit, Michigan, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, 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, Saint Louis, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Hackensack University Medical Center, Hackensack, New Jersey, United States

Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Columbia Presbyterian Hospital, New York, New York, United States

State University of New York - Upstate Medical University, Syracuse, New York, United States

Graham Children's Health Center, Asheville, North Carolina, United States

Duke Comprehensive Cancer Center, Durham, North Carolina, United States

Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, United States

Children's Hospital of Columbus, Columbus, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States

Medical University of South Carolina, Charleston, South Carolina, United States

Vanderbilt Cancer Center, Nashville, Tennessee, United States

Simmons Cancer Center - Dallas, Dallas, Texas, United States

Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States

Texas Children's Cancer Center, Houston, Texas, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

Primary Children's Medical Center, Salt Lake City, Utah, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States

Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States

Royal Children's Hospital, Parkville, Victoria, Australia

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

Hospital for Sick Children, Toronto, Ontario, Canada

Montreal Children's Hospital, Montreal, Quebec, Canada

Hopital Sainte Justine, Montreal, Quebec, Canada

Contact Details

Name: Denise Adams, MD

Affiliation: University of Vermont

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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