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 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT00470366
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed germ cell tumor meeting 1 of the following criteria:
* Poor risk, defined by any of the following:
* Testis or retroperitoneal primary site nonseminoma histology without visceral metastases but with "poor-risk" markers, defined by any of the following:
* Pretreatment serum lactate dehydrogenase (LDH) \> 10 times upper limit of normal (ULN)
* Pretreatment serum human chorionic gonadotropin (HCG) \> 50,000 IU/L
* Pretreatment serum alpha fetoprotein (AFP) \> 10,000 ng/mL
* Testis or retroperitoneal primary site nonseminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values):
* Bone metastases
* Brain metastases
* Hepatic metastases
* Any nonpulmonary metastases (i.e., skin, spleen)
* Mediastinal primary site nonseminoma histology regardless of serum tumor marker levels or presence/absence of visceral metastases
* Modified intermediate risk, defined by any of the following:
* Testis or retroperitoneal primary site nonseminoma histology with no nonpulmonary visceral metastases, and with any of the following serum marker values:
* Pretreatment serum LDH 3.0-10 times ULN
* Pretreatment serum HCG 5,000-50,000 IU/L
* Pretreatment serum AFP 1,000-10,000 ng/mL
* Seminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values or primary site):
* Bone metastases
* Brain metastases
* Hepatic metastases
* Any nonpulmonary visceral metastases (i.e., skin, spleen)
* Previously untreated disease
* Measurable or evaluable disease
PATIENT CHARACTERISTICS:
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine normal or creatinine clearance \> 50 mL/min (unless renal dysfunction is due to tumor obstructing the ureters)
* AST and ALT ≤ 3 times ULN
* Bilirubin ≤ 2.0 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent malignancy except for nonmelanoma skin cancer
* No known HIV positivity
* No active infections
PRIOR CONCURRENT THERAPY:
* Recovered from prior surgery
* More than 30 days since prior radiotherapy and recovered (unless evidence of progressive disease has been documented)
* No prior chemotherapy
* No other concurrent cytotoxic therapy
* Concurrent radiotherapy and surgery allowed for treatment of brain metastases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00470366
Study Brief:
Protocol Section:
NCT00470366