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 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT00006095
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed initial diagnosis of malignant solid tumor refractory to conventional therapy or for which no effective therapy exists
* Brain tumors allowed if not on anticonvulsants
* Brainstem gliomas allowed without histologic diagnosis
* Solid lymphomas allowed
* No bone marrow involvement
PATIENT CHARACTERISTICS:
Age:
* 1 to 21
Performance status:
* Karnofsky 50-100% if over 10 years of age
* Lansky 50-100% if 10 years of age and under
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 8 g/dL (transfusion allowed)
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* ALT less than 5 times normal
* Albumin at least 2 g/dL
Renal:
* Creatinine normal for age OR
* Glomerular filtration rate normal for age
Other:
* No uncontrolled infection
* No other significant systemic illness
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 1 week since prior biologic therapy and recovered
* At least 1 week since prior growth factors
* No prior stem cell transplantation
Chemotherapy:
* At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
* No more than 2 prior chemotherapy regimens
* No other concurrent cancer chemotherapy
Endocrine therapy:
* Concurrent dexamethasone allowed in patients with CNS tumors provided dose is stable or decreasing for at least 2 weeks prior to study
Radiotherapy:
* Recovered from prior radiotherapy
* At least 2 weeks since prior local palliative radiotherapy (small port)
* No prior substantial bone marrow radiotherapy
* No prior central axis radiotherapy
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* No concurrent anticonvulsants
* No other concurrent anticancer therapy or investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
21 Years
Study:
NCT00006095
Study Brief:
Protocol Section:
NCT00006095