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:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-24 @ 12:16 PM
NCT ID:
NCT00098761
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed\* primary brain tumor, including benign brain tumors (e.g., low-grade glioma)
* Recurrent or progressive disease OR refractory to standard therapy NOTE: \*Patients with intrinsic brain stem or diffuse optic pathway tumors do not require histological confirmation, but must have clinical and/or radiographic evidence of disease progression
* No bone marrow disease
PATIENT CHARACTERISTICS:
Age
* 21 and under
Performance status
* Karnofsky 50-100% (for patients \> 16 years of age) OR
* Lansky 50-100% (for patients ≤ 16 years of age)
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,000/mm\^3\*
* Platelet count ≥ 100,000/mm\^3\*
* Hemoglobin ≥ 8 g/dL\* NOTE: \*Unsupported
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT and AST ≤ 2.5 times ULN
* No overt hepatic disease
Renal
* BUN \< 25 mg/dL
* Creatinine ≤ 1.5 times ULN for age OR
* Glomerular filtration rate \> 70 mL/min
* No overt renal disease
Cardiovascular
* Shortening fraction ≥ 30% by echocardiogram OR
* Ejection fraction ≥ 50% by gated radionucleotide study
* No clinically significant cardiac arrhythmia by EKG
* No overt cardiac disease
Pulmonary
* DLCO ≥ 60% of predicted
* Chest X-ray normal (defined as absence of pulmonary infiltrates, pneumonitis, pleural effusion, pulmonary hemorrhage, or fibrosis) AND a resting pulse oximetry reading of \> 94% in room air (for patients who cannot perform the DLCO)
* No overt pulmonary disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Neurologic deficits allowed provided there has been no deficit progression for ≥ 1 week before study entry
* No uncontrolled infection
* No known hypersensitivity to polyethylene glycol
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 6 months since prior allogeneic bone marrow or stem cell transplantation
* At least 3 months since prior autologous bone marrow or stem cell transplantation
* More than 1 week since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa)
* At least 3 weeks since prior myelosuppressive anticancer biologic therapy
* No concurrent routine colony-stimulating factors
Chemotherapy
* At least 3 weeks since prior myelosuppressive anticancer chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy
* Concurrent corticosteroids allowed provided dose is stable or decreasing for ≥ 1 week before study entry
Radiotherapy
* At least 3 months since prior craniospinal irradiation ≥ 18 Gy
* At least 2 weeks since prior focal irradiation to the primary tumor and/or symptomatic metastatic sites
Surgery
* Not specified
Other
* At least 7 days since prior nonmyelosuppressive anticancer therapy
* At least 7 days since prior investigational agents
* Concurrent enzyme-inducing anticonvulsant drugs allowed
* No other concurrent anticancer or experimental agents or therapies
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00098761
Study Brief:
Protocol Section:
NCT00098761