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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT00003194
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven recurrent or refractory pediatric solid tumor
* Bone marrow metastases allowed
PATIENT CHARACTERISTICS:
Age:
* 1 to 30
Performance status:
* 0-2
Life expectancy:
* At least 2 months
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm3
* Platelet count at least 100,000/mm3 (transfusion independent)
* Hemoglobin at least 10 g/dL (RBC transfusion allowed)
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 2.5 times normal
Renal:
* Adequate renal function as defined by one of the following:
* GFR by creatinine clearance
* Radioisotope GFR
* Iothalamate at least 70 mL/min
Cardiovascular:
* Adequate cardiac function as defined by one of the following:
* Ejection fraction at least 55% by MUGA
* Fractional shortening at least 28% by echocardiogram
Neurologic:
* Adequate CNS function as defined by:
* Seizure disorder, if present, controlled by anticonvulsants
* CNS toxicity no greater than grade 2
Other:
* No uncontrolled infections
* Not pregnant or nursing
* No allergy to platinum compounds
* No history of allergy to etoposide (unless mobilization phase not required)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Recovered from prior immunotherapy
* At least 1 week since prior cytokines
* At least 3 months since prior bone marrow or peripheral blood stem cell transplantation
* No concurrent immunomodulator
* No concurrent cytokines
Chemotherapy:
* At least 3 weeks (6 for nitrosourea) since prior chemotherapy and recovered
* No prior thiotepa
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Recovered from prior radiotherapy
* At least 6 months since prior total body irradiation conditioning
* No concurrent radiotherapy to greater than 10% of total liver, lung, or bone marrow
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
30 Years
Study:
NCT00003194
Study Brief:
Protocol Section:
NCT00003194