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

Exclusion Criteria

• •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