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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT00006102
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed solid tumors
* Neuroblastoma
* Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)(Ewing's sarcoma closed to accrual as of 5/19/03)
* Osteosarcoma (closed to accrual as of 5/19/03)
* Rhabdomyosarcoma
* Other extracranial solid tumors
* CNS/brain tumors:
* Medulloblastoma/PNET
* Ependymoma
* Brainstem glioma
* Other CNS tumors
* Histological verification may be waived for brainstem glioma and classic optic glioma, but biopsy recommended OR
* Histologically or cytologically proven non-Hodgkin's lymphoma
* Refractory to standard treatment and no curative therapy available
* Measurable disease
PATIENT CHARACTERISTICS:
Age:
* 21 and under at time of original diagnosis
Performance status:
* Karnofsky 50-100% in patients over 10 years of age
* Lansky 50-100% in patients age 10 and under
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 75,000/mm\^3
* Hemoglobin greater than 8.0 g/dL
Hepatic:
* Bilirubin normal for age
* SGPT less than 2.5 times upper limit of normal
* Amylase normal
* Lipase normal
Renal:
* Creatinine normal for age OR
* Glomerular filtration rate at least 60 mL/min
Other:
* No concurrent uncontrolled infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Recovered from prior immunotherapy
Chemotherapy:
* At least 6 weeks since prior nitrosourea and recovered
* Recovered from any other prior chemotherapy
* No more than two prior chemotherapy regimens
Endocrine therapy:
* CNS tumor patients receiving dexamethasone must be on stable or decreasing dose at least 2 weeks prior to study entry
Radiotherapy:
* At least 6 weeks since prior extended radiotherapy and recovered
* No prior total body irradiation
Surgery:
* Prior radiosurgery allowed
Other:
* No concurrent use of the following foods or medications:
* Grapefruit juice
* Erythromycin
* Azithromycin
* Clarithromycin
* Rifampin and analogues
* Fluconazole
* Ketoconazole
* Itraconazole
* Cimetidine
* Cannabinoids (marijuana or dronabinol)
* Leukotriene inhibitors (e.g., zafirlukast and zileuton)
* No other concurrent anticancer or investigational agents
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00006102
Study Brief:
Protocol Section:
NCT00006102