Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
NCT ID: NCT00005602
Last Updated: 2014-02-21
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
13 participants
INTERVENTIONAL
2001-02-28
2005-09-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with carboplatin and lobradimil in treating children who have newly diagnosed brain stem gliomas.
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Detailed Description
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* Determine the maximum tolerated duration of lobradimil plus carboplatin with radiotherapy in patients with newly diagnosed brain stem gliomas.
* Determine the toxic effects of this treatment regimen in these patients.
* Assess the response to radiotherapy in patients treated with this regimen.
OUTLINE: Patients receive radiotherapy for 5 consecutive days a week for 6.5 weeks, for a total of 33 doses. Patients receive carboplatin IV over 15 minutes followed by lobradimil IV over 10 minutes concurrently with radiotherapy.
The first cohort of 3-6 patients receives treatment with carboplatin and lobradimil for the first three weeks of radiotherapy, with the duration of chemotherapy increasing by one week with each subsequent cohort until the maximum duration of 6.5 weeks is reached or until unacceptable toxicity occurs in 2 of 6 patients.
Patients are followed at 6 weeks; every 3 months for 2 years; every 6 months for 3 years; and then annually thereafter.
PROJECTED ACCRUAL: A total of 15-24 patients will be accrued for this study within 36 months.
Conditions
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Study Design
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TREATMENT
Study Groups
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Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days
carboplatin
cereport
radiation therapy
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days
carboplatin
cereport
radiation therapy
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days
carboplatin
cereport
radiation therapy
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days
carboplatin
cereport
radiation therapy
Interventions
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carboplatin
cereport
radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed diffuse, intrinsic brain stem gliomas
* Measurable disease
* No disseminated disease at sites other than brain stem
* No neurofibromatosis
* Treatment must begin within 31 days of diagnosis
* Date of diagnosis will be considered date of surgery in patients undergoing surgical biopsy
PATIENT CHARACTERISTICS:
Age:
* 3 to 21
Performance status:
* Karnofsky 50-100% (over 10 years of age)
* Lansky 50-100% (10 years of age and under)
Life expectancy:
* At least 2 months
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGPT no greater than 2.5 times ULN (4.0 times ULN with antiepileptic or steroid medications)
Renal:
* Creatinine less than ULN for age OR
* Creatinine clearance or glomerular filtration rate greater than 80 mL/min
Other:
* No history of severe allergic reaction to any platinum-containing compound
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent growth factors during therapy with carboplatin
Chemotherapy
* Not specified
Endocrine therapy
* Prior corticosteroids for brain stem glioma are allowed
Radiotherapy
* Not specified
Surgery
* Prior surgery for brain stem glioma is allowed
Other
* At least 24 hours since any of the following medications:
* Vasodilating compounds
* Angiotensin-converting enzyme inhibitors
* Calcium channel blockers
* Beta blockers
* No other prior therapy for brain stem glioma
3 Years
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Roger J. Packer, MD
Role: STUDY_CHAIR
Children's National Research Institute
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Albert Einstein Clinical Cancer Center
The Bronx, New York, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
Doernbecher Children's Hospital
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Countries
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Other Identifiers
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COG-ADVL0012
Identifier Type: OTHER
Identifier Source: secondary_id
CCG-ADVL0012
Identifier Type: OTHER
Identifier Source: secondary_id
ALK-01-042
Identifier Type: -
Identifier Source: secondary_id
CCG-09802
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000067715
Identifier Type: OTHER
Identifier Source: secondary_id
ADVL0012
Identifier Type: -
Identifier Source: org_study_id
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