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 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 12:09 AM
NCT ID:
NCT00107458
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed\* malignant solid tumor, including CNS tumors, at original diagnosis or relapse
* Recurrent or refractory disease NOTE: \*Histologic confirmation not required for intrinsic brain stem or optic pathway tumors
* Measurable or evaluable disease, defined by 1 of the following criteria:
* Any unidimensionally measurable lesion ≥ 10 mm by standard MRI or CT scan for either solid or CNS tumors
* At least 1 nonmeasurable lesion that is evaluable by nuclear medicine, immunocytochemistry, tumor markers, cerebrospinal fluid cytology, or other reliable measures
* No known curative therapy exists
* No documented tumor involvement in the bone marrow
PATIENT CHARACTERISTICS:
Age
* 2 to 21
Performance status\*
* Lansky 50-100% (for patients ≤ 10 years of age)
* Karnofsky 50-100% (for patients \> 10 years of age)
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3 (transfusion independent)
* Hemoglobin ≥ 8.0 g/dL (transfusions allowed)
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT ≤ 110 (ULN for this study is 45 U/L)
* Albumin ≥ 2 g/dL
Renal
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
* Creatinine based on age as follows:
* No greater than 0.8 mg/dL (for patients ≤ 5 years of age)
* No greater than 1.0 mg/dL (for patients 6 to 10 years of age)
* No greater than 1.2 mg/dL (for patients 11 to 15 years of age)
* No greater than 1.5 mg/dL (for patients over 15 years of age)
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Neurologic deficits in patients with CNS tumors must be stable for ≥ 1 week before study entry
* No uncontrolled infection
* No known urea cycle disorders or other metabolic disorders
* No other condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Recovered from prior immunotherapy
* At least 7 days since prior hematopoietic growth factors that support platelet or WBC number or function
* At least 7 days since prior antineoplastic biologic agents
* At least 3 months since prior stem cell transplantation or rescue without total body irradiation
* No evidence of active graft vs host disease
* No other concurrent anticancer biologic therapy or immunotherapy
Chemotherapy
* More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
* No other concurrent anticancer chemotherapy
Endocrine therapy
* Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for the past 7 days
Radiotherapy
* See Biologic therapy
* Recovered from prior radiotherapy
* At least 6 months since prior total body irradiation, craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis
* At least 6 weeks since other prior substantial bone marrow radiotherapy
* At least 2 weeks since prior local palliative small port radiotherapy
* No concurrent anticancer radiotherapy
Surgery
* Not specified
Other
* No other concurrent investigational agents
* No other concurrent anticancer agents
* No other concurrent anticonvulsants
* Patients receiving valproic acid (VPA) before study entry must have a total trough VPA concentration \< 100 mcg/mL within the past 7 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
21 Years
Study:
NCT00107458
Study Brief:
Protocol Section:
NCT00107458