Gemcitabine Hydrochloride, Paclitaxel, Oxaliplatin, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Patients with Recurrent or Refractory Central Nervous System Germ Cell Tumors

Inclusion Criteria

• Patients must be enrolled before treatment begins; the date protocol therapy is to start must be no later than 42 days from the time of recurrence and within 7 days from enrollment
• CNS GCT including pure germinoma and MMGCT; patients with histologically proven germinoma and MMGCT, including endodermal sinus tumor (yolk sac tumor), embryonal carcinoma, choriocarcinoma and mixed germ cell tumor will be eligible for the study; patients with mature/immature teratoma who have tumor marker elevations are eligible on this study; patient with ONLY mature and/or immature teratoma are ineligible in the absence of the tumor marker elevations
• Lumbar CSF must be assayed for cytology, alpha fetoprotein (AFP) and beta human chorionic gonadotrophin (HCGbeta); a quantitative serum determination of AFP and HCGbeta should be performed at the time of the lumbar CSF assay
• For the diagnosis of pure germinoma, HCGbeta (serum and CSF) must be =< 100 mIU/ml, serum AFP must be =< 10 IU/l (ng/ml) and =< institutional norm and initial CSF AFP =< 2 IU/l (ng/ml) and =< institutional norm with histologically proven diagnosis of germinoma at diagnosis or subsequent relapse
• For histologically unconfirmed MMGCT, serum and/or CSF tumor markers of HCGbeta > 100 mIU/ml or any elevation of above AFP > 10 IU/L (ng/ml) and/or above institutional norm in the serum and CSF AFP >= 2 IU/L (ng/ml) and/or institutional norm
• Patients with no elevations of serum and/or CSF HCGbeta and AFP must have histological diagnosis of malignant GCT or germinoma
• Patient must either have recurrence of CNS GCT or should be refractory to initial therapy
• Magnetic resonance imaging (MRI) scans of the brain and spine must be completed within 21 days prior to patient registration; all MRI scans should be with and without gadolinium
• All patients who do not have surgery performed must have MRI scans obtained prior to induction
• All patients who have surgery performed must have a cranial MRI pre-operative and post-operative (should be done within 72 hours of surgery or within 21 days following surgery)
• A MRI of the spine is required within 10 days prior to or at least 10 days after surgery
• Serum HCGbeta and AFP levels must be assessed within 7 days prior to registration
• Patient must have lumbar CSF for cytology, protein, AFP and HCGbeta within 7 days prior to registration
• Have a Karnofsky performance status greater than or equal to 50 for patients aged 16 years or older and a Lansky performance status greater than or equal to 50 for patients less than 16 years old
• Life expectancy must be >= 8 weeks
• Must not have received cytotoxic chemotherapy within 14 days of entry on to this study
• Patient must not have received any prior marrow-ablative chemotherapy and autologous hematopoietic cell transplant
• Patient must have not received gemcitabine, oxaliplatin and/or paclitaxel chemotherapy agents
• Must not have received any biological modifier within 14 days of entry on to this study
• At least 4 weeks for focal radiation therapy (RT) or >= 6 weeks for craniospinal RT must have elapsed prior to study entry
• Patient must have recovered from the surgery
• Corticosteroid therapy and endocrine replacement therapy (L-thyroxine, testosterone, estrogen, desmopressin acetate [DDAVP]) are permissible; any patient already receiving human growth replacement therapy should discontinue this prior to commencing chemotherapy, and should not restart until 3 years from diagnosis
• Appropriate antibiotics, blood products, anti-emetics, fluids, electrolytes and general supportive care are to be used as necessary
• Concomitant use of any enzyme inducing anticonvulsants is not allowed
• Absolute neutrophil count (ANC) greater than or equal to 750/mm^3
• Platelets (Plts) greater than or equal to 75,000/mm^3 (transfusion independent)
• Hemoglobin (Hgb) greater than 8.0 g/dL (may have packed red blood cell [PRBC] transfusion)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal for age
• Total bilirubin =< 2 x institutional upper limit of normal for age
• Liver function test must be obtained within 14 days prior to registration
• Patients must have adequate renal function defined as < 1.5 x normal serum creatinine as adjusted for age: Age: < 5 years; maximum serum creatinine: 0.8 mg/dL Age: > 5 and < 10 years; maximum serum creatinine: 1.0 mg/dL Age: > 10 and < 15 years; maximum serum creatinine: 1.2 mg/dL Age: > 15 years; maximum serum creatinine: 1.5 mg/dL
• Or a calculated or measured creatinine clearance or radioisotope GFR >= 70ml/min/1.73m^2 obtained within 14 days prior to registration
• Patients who are pregnant or breast-feeding are not eligible; nursing mothers must agree not to breastfeed during therapy; females of childbearing potential must practice an effective method of birth control while participating in this study and for those who have achieved menarche, must have a negative pregnancy test prior to study entry
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional and Food and Drug Administration (FDA) requirements for human studies must be met

Exclusion Criteria

• Patients with CNS GCTs who are newly diagnosed are excluded from the study
• Patients with the diagnosis of mature or immature teratoma in the absence of tumor marker elevations are excluded from the study
• Patients who are pregnant or breastfeeding are excluded from the study
• Patients who have received previously a high dose chemotherapy regimen and autologous transplant are excluded from this study
• Patients who have received gemcitabine, oxaliplatin and/or paclitaxel are excluded from this study