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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT00293358
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Clinical and radiological evidence of intracranial germ cell tumor, classified as 1 of the following:
* Germinoma
* Pure germinoma
* Germinoma with mature and/or immature teratoma
* Secreting germ cell tumor
* Elevated tumor markers in serum and/or cerebral spinal fluid as evidenced by any of the following:
* Alpha-fetoprotein \> 25 ng/mL
* β-human choriogonadotropin \> 50 IU/L
* Any tumor containing 1 of these components:
* Yolk sac tumor
* Choriocarcinoma
* Embryonal tumor
* Normal tumor markers allowed
* Diagnosis confirmed by histology or elevated serum markers
* Metastatic or nonmetastatic disease
* Two separate tumors in the suprasellar and pineal areas without evidence of metastatic disease elsewhere are considered nonmetastatic multifocal disease
* Study treatment must begin ≤ 4 weeks after diagnosis
* No pure immature or mature teratomas
* The following additional patients are eligible:
* Patients who are \> 18 years of age provided no other appropriate protocol exists
* Patients who were diagnosed \> 4 weeks ago
* Patients who are in relapse
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* No prior treatment except surgery
* No concurrent amino glycosides or other nephrotoxic drugs during ifosfamide administration
* No concurrent growth factors
* No other concurrent chemotherapy or radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00293358
Study Brief:
Protocol Section:
NCT00293358