Ensayos clínicos

Inclusion Criteria

• Newly diagnosed with localized primary CNS non germinomatous germ cell tumor (NGGCT) (Stratum 1). Stratum 1( NGGCT) patients must have one of the following criteria
  • Serum and/or CSF hCGβ > 100 mIU/mL
  • Any elevation of serum and CSF alpha-fetoprotein (AFP) > 10 ng/mL 
  • Greater than the institutional normal , irrespective of biopsy results
  • Any of the following elements on biopsy/resection, irrespective of serum and/or CSF hCGβ and AFP levels:
    • endodermal sinus tumor (yolk sac)
    • embryonal carcinoma
    • choriocarcinoma
    • malignant/immature teratoma, 
    • mixed GCT with malignant GCT elements
• Or localized primary CNS germinoma (Stratum 2). Stratum 2 (Germinoma) must have one of the following criteria
  • Institutional normal AFP AND hCGβ 5 to ≤ 50 mIU/mL in serum and/or CSF, no histologic confirmation required
  • Bifocal (pineal + suprasellar) involvement or pineal lesion with diabetes insipidus AND hCGβ ≤ 100 mIU/mL and institutional normal AFP in serum and/or CSF, no histologic confirmation required
  • Histologically confirmed germinoma or germinoma mixed with mature teratoma and hCGβ ≤ 100 mIU/mL and institutional normal AFP in serum and/or CSF
• germ cell tumors (GCTs) located in the suprasellar, pineal, bifocal (pineal +suprasellar), and ventricles
• tumors present in the above mentioned locations and with unifocal parenchymal extension
• Must have negative lumbar CSF cytology
  • lumbar CSF must be obtained unless medically contraindicated
• Must be enrolled on ALTE07C1 prior to enrollment on ACNS1123
• Peripheral absolute neutrophil count (ANC) ≥ 1,000/μL
• Platelet count ≥ 100,000/μL (transfusion independent)
• Hemoglobin ≥ 8.0 g/dL (may receive red blood cell [RBC] transfusions)
• Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m²
• OR serum creatinine based on age/gender as follows
  • 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)
  • 1.5 mg/dL (male) and 1.4 mg/dL (female) (13 to < 16 years of age)
  • 1.7 mg/dL (male) and 1.4 mg/dL (female) (≥ 16 years of age)
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvate transaminase(SGPT) (alanine aminotransferase [ALT]) < 2.5 times ULN
• Patients with seizure disorder if well controlled
• Patients who had more than 1 prior surgery/biopsy are eligible

Exclusion Criteria

• Patients with mature teratoma with normal tumor markers
• Patients with tumors located outside the ventricles (basal ganglia, thalamus)
• Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology
• Must not be in status, coma, or assisted ventilation prior to study enrollment
• Female patients who are pregnant
• Lactating females unless they have agreed not to breastfeed their infants
• Female patients of childbearing potential unless a negative pregnancy test result has been obtained
• Sexually active patients of reproductive potential unless they have agreed to use an effective contraceptive method for the duration of their study participation
• Must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids.