Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas
3 Years
21 Years
Both
Brain and Central Nervous System Tumors
Trial Information
Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Roger J. Packer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Children's Research Institute
Authority:
United States: Federal Government
Study ID:
CDR0000067715
NCT ID:
NCT00005602
Start Date:
February 2001
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- untreated childhood brain stem glioma
- Glioma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| State University of New York - Upstate Medical University | Syracuse, New York 13210 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
| Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Children's Hospital Medical Center - Cincinnati | Cincinnati, Ohio 45229-3039 |
| Doernbecher Children's Hospital | Portland, Oregon 97201-3098 |
| Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
| Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
| Albert Einstein Clinical Cancer Center | Bronx, New York 10461 |
| Lucile Packard Children's Hospital at Stanford | Palo Alto, California 94304 |
