O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors
NCT ID: NCT00003765
Last Updated: 2013-02-05
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
PHASE1
36 participants
INTERVENTIONAL
1999-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
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.
O6-benzylguanine
carmustine
Interventions
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O6-benzylguanine
carmustine
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically proven CNS tumor that is refractory to conventional therapy or for which no effective therapy is known
* Histological requirement may be waived for brainstem and optic gliomas
* Stratum 2: No bone marrow involvement
PATIENT CHARACTERISTICS:
* Age: 21 and under
* Performance status: Karnofsky 50-100% OR Lansky 50-100%
* Life expectancy: At least 8 weeks
* Absolute neutrophil count at least 1500/mm3
* Platelet count at least 100,000/mm3 (stratum 2: at least 125,000/mm3)
* Hemoglobin at least 8 g/dL
* Bilirubin less than 1.5 mg/dL
* SGOT/SGPT no greater than 2.5 times normal
* Creatinine or GFR normal for age
* If required, DLCO must be 80% of normal and patient old enough to cooperate for DLCO test
* Neurologic deficits must be stable for at least 2 weeks prior to study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
PRIOR CONCURRENT THERAPY:
* At least 7 days since prior biologic therapy or immunotherapy and recovered
* At least 6 months since prior bone marrow transplant (stratum 1 only)
* At least 7 days since prior growth factors
* No concurrent filgrastim (G-CSF) prophylaxis
* Stratum 2: No prior bone marrow transplantation
* At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered
* Stratum 2: No greater than 2 prior chemotherapy regimens
* No prior nitrosourea therapy
* If receiving dexamethasone, must be on stable or decreasing dose for at least 2 weeks prior to study
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 6 months since prior substantial bone marrow radiation, total body irradiation, hemipelvic radiotherapy, or total abdominal/pelvic/chest or mantle/Y ports radiotherapy
* Recovered from prior radiotherapy
* Stratum 2: No prior central axis radiation
* No other concurrent anticancer or investigational agents
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Denise Adams, MD
Role: STUDY_CHAIR
University of Vermont
Locations
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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 D.C., 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
St Louis, Missouri, United States
Washington University School of Medicine
St 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
Countries
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References
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Adams DM, Zhou T, Berg SL, Bernstein M, Neville K, Blaney SM; Children's Oncology Group. Phase 1 trial of O6-benzylguanine and BCNU in children with CNS tumors: a Children's Oncology Group study. Pediatr Blood Cancer. 2008 Mar;50(3):549-53. doi: 10.1002/pbc.21362.
Other Identifiers
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POG-9870
Identifier Type: -
Identifier Source: secondary_id
CDR0000066891
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-01842
Identifier Type: -
Identifier Source: org_study_id
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