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 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT00274950
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically\* proven extracranial malignant germ cell tumor (GCT), including mature/immature teratoma, with or without elevated alpha-fetoprotein (AFP) or human chorionic gonadotropin (HCG) levels
* Newly diagnosed disease
* Patients with relapsed or progressive extracranial malignant GCT allowed if previously treated with carboplatin, etoposide, and bleomycin (JEB) chemotherapy
* Patients relapsing following JEB are eligible for the study relapse strategy NOTE: \*Patients with unequivocally raised AFP/HCG whose risk of biopsy is felt to be high can be diagnosed by clinical grounds, imaging, and markers
* No intracranial GCTs
PATIENT CHARACTERISTICS:
* Neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* ALT ≤ 3 times ULN
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy other than JEB
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT00274950
Study Brief:
Protocol Section:
NCT00274950