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 @ 4:24 AM
Ignite Modification Date:
2025-12-25 @ 4:24 AM
NCT ID:
NCT00047320
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* One of the following diagnoses:
* Histologically confirmed intracranial non-germinomatous germ cell tumor (NGGCT) of 1 of the following types:
* Endodermal sinus tumor (yolk sac tumor)
* Embryonal carcinoma
* Choriocarcinoma
* Immature teratoma and teratoma with malignant transformation
* Mixed germ cell tumor
* Histologically confirmed germinoma with elevation of serum/CSF beta human chorionic gonadotropin (HCG) levels greater than 50 mIU/mL or any serum/CSF alpha-fetoprotein (AFP) levels greater than 10 ng/ml or above institutional norm
* Histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF beta HCG levels greater than 50 mIU/mL or AFP levels greater than 10 ng/ml or above institutional norm
* Patients with normal AFP and beta HCG \< 50 mIU/mL without histologic diagnosis of a NGGCT or patients with pure germinoma without elevation of tumor marker are ineligible
* Initial diagnosis within the past 31 days
PATIENT CHARACTERISTICS:
Age
* 3 to 24 at diagnosis
Performance status
* No minimum performance level
Life expectancy
* At least 8 weeks
Hematopoietic
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3 (transfusion independent)
* Hemoglobin at least 10.0 g/dL (transfusion allowed)
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT no greater than 2.5 times ULN
Renal
* Creatinine no greater than 1.5 times ULN OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Pulmonary
* No assisted ventilation
Other
* Seizure disorders allowed
* No patients in status or coma
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patient must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Prior corticosteroids allowed
* Concurrent corticosteroids allowed
* Concurrent endocrine replacement therapy allowed (e.g., L-thyroxine, testosterone, estrogen, desmopressin acetate)
* No concurrent growth hormone therapy
Radiotherapy
* Not specified
Surgery
* More than 1 prior surgery allowed
Other
* No other prior therapy for malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
24 Years
Study:
NCT00047320
Study Brief:
Protocol Section:
NCT00047320