Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors

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