Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors

Inclusion Criteria

• Poor prognosis non-seminomas germ cell tumor in >= partial response (PR)1/complete response (CR)1 or good or intermediate prognosis seminomas and non-seminomas germ cell tumor in >= PR1 or >= CR2 as defined by the International Germ Cell Cancer Consensus Classification; patients with increasing tumor markers only (i.e., no imaging evidence of progressive disease) are eligible for transplant
• Performance status: Karnofsky >= 80% (subjects >= 16 years of age); Lansky >= 80% (for subjects 10-15 years of age)
• Life expectancy greater than 8 weeks
• Hemoglobin > 8 gm/dL without transfusion and off erythropoietin for 14 days or Aranesp for 21 days
• White blood cell (WBC) > 2.5 x 10^9/L with an absolute neutrophil count (ANC) > 1.5 x 10^9/L and off granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) for 10 days or Neulasta for 21 days
• Platelets > 100 x 10^9/L without transfusion and/or a bone marrow cellularity of >= 20%
• Creatinine =< 2.0 mg/dl or creatinine clearance > 50 ml/min
• Total bilirubin =< 2.0 mg/dl
• Aspartate aminotransferase (AST) and alkaline phosphatase < 5 x upper limit of normal
• No history of severe prior or ongoing chronic liver disease
• Patients must be free of symptoms of uncontrolled cardiac disease including unstable angina, decompensated congestive heart failure, or arrhythmia
• Left ventricular ejection fraction (LVEF) >= 45% by multi gated acquisition scan (MUGA)/echocardiogram (ECHO)
• Patients must have no significant obstructive airways disease (forced expiratory volume in one second [FEV1] must be >= 50% of predicted) and must have acceptable diffusion capacity (corrected diffusion capacity of carbon monoxide [DLCO] > 50% of predicted)
• Patients with a history of central nervous system (CNS) tumor involvement are eligible if they have completed treatment for CNS disease (radiotherapy or surgery or chemotherapy), have recovered from or stabilization of the side effects associated with the therapy and have no evidence of progressive CNS disease at the time of enrollment
• Patients with serious uncontrolled infections will not be eligible
• Male and female patients of reproductive potential must use an approved contraceptive method if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for the duration of study participation; the drugs used in this study are pregnancy category D – clear evidence of risk in pregnancy; pregnant and breastfeeding women will not be eligible
• Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
• Additional Eligibility Prior to Transplant Two:
• Total Collection of >= 4 x 10^6 CD34 cells/kg prior to transplant one
• Transplant able to occur between day +30 and day +90 from transplant one
• WBC > 2.5 x 10^9/L with an ANC > 1.5 x 10^9/L and off G-CSF for 3 days
• Platelets > 50 x 10^9/L without transfusion in the prior 7 days
• Creatinine =< 2.0 mg/dl or creatinine clearance > 50 ml/min
• Total bilirubin =< 2.0 mg/dl
• AST and alkaline phosphatase < 5 x upper limit of normal
• Patients with serious uncontrolled infections at the time of planned transplant will be excluded
• Patients with progressive disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria by imaging techniques are not eligible to proceed to the second transplant; tumor marker increase alone is not sufficient to diagnose disease progression