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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT00467051
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed (at original diagnosis) extracranial germ cell tumor (GCT) containing 1 of the following malignant elements:
* Yolk sac tumor (endodermal sinus tumor)
* Choriocarcinoma
* Embryonal carcinoma
* Meets 1 of the following disease criteria:
* Recurrent malignant disease
* Chemotherapy-resistant disease
* Relapsed disease
* Disease refractory to conventional therapy
* Measurable disease
* Must have received a prior first-line chemotherapy regimen that included cisplatin
* Patients with tumor marker (AFP and/or BHCG) elevation alone or bone scan findings alone are not eligible\*
* Patients with immature teratoma (any grade), germinoma, sex-cord stromal tumors, or recurrent GCT previously treated with surgery alone are not eligible
* Karnofsky performance status (PS) 50-100% (age \> 16 years) OR Lansky PS 50-100% (age ≤ 16 years) OR ECOG PS 0-2
* Life expectancy ≥ 8 weeks
* Absolute neutrophil count ≥ 750/mm³
* Platelet count ≥ 75,000/mm³ (transfusion independent)
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal based on age/gender, as defined by the following:
* ≤ 0.4 mg/dL (1 month to \< 6 months of age)
* ≤ 0.5 mg/dL (6 months to \< 1 year of age)
* ≤ 0.6 mg/dL (1 to \< 2 years of age)
* ≤ 0.8 mg/dL (2 to \< 6 years of age)
* ≤ 1.0 mg/dL (6 to \< 10 years of age)
* ≤ 1.2 mg/dL (10 to \< 13 years of age)
* ≤ 1.4 mg/dL (13 to ≥ 16 years of age) (female)
* ≤ 1.5 mg/dL (13 to \< 16 years of age) (male)
* ≤ 1.7 mg/dL (≥ 16 years of age) (male)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
* ALT \< 2.5 times ULN for age
* Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by gated radionuclide study
* No dyspnea at rest
* No exercise intolerance
* Pulse oximetry \> 94% (if there is clinical indication for determination)
* Patients with seizure disorder are eligible provided they are on non-enzyme inducing anticonvulsants and seizures are well controlled
* No CNS toxicity \> grade 2
* No active graft-versus-host disease
* No allergy to Cremophor EL or castor oil
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other concurrent chemotherapy or immunomodulating agents
* Recovered from prior chemotherapy, immunotherapy, or radiotherapy
* At least 1 week since prior growth factors (2 weeks for pegfilgrastim)
* At least 1 week since prior biologic therapy
* At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea)
* At least 2 weeks since prior local palliative radiotherapy (i.e., small port)
* At least 6 months since prior craniospinal radiotherapy or radiotherapy to ≥ 50% of pelvis
* At least 6 weeks since other prior substantial bone marrow radiotherapy
* At least 6 months since prior allogeneic stem cell transplantation
* Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00467051
Study Brief:
Protocol Section:
NCT00467051