Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT00005602
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
21 Years
Study:
NCT00005602
Study Brief:
Protocol Section:
NCT00005602