High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors

Korábbi kezelés

• Major surgery within 30 days before the initiation of study treatment
• Radiotherapy within 21 days prior to initiation of study treatment
• Prior whole brain irradiation.
• Patients who have had a previous autologous or allogeneic stem cell transplant in the previous 12 months.
• Positive pregnancy test in a female patient of childbearing potential defined as not post menopausal for twelve months or no previous surgical sterilization.

Más betegség

• Patients with active central nervous system (CNS) disease, defined as brain or meningeal metastases that are not in complete remission.
• Patients with active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/=10,000 copies/mL, or >/= 2,000 IU/mL).
• Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients who either show chronic hepatitis C or positive hepatitis C serology.
• Active infection requiring parenteral antibiotics.

Laborértékek

• Growing teratoma syndrome, defined as enlarging tumor masses with normal serum markers during chemotherapy for nonseminomatous GCT.
• HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts

• Male or female patients, age 12 to 65 years.
• Patients with seminomatous or nonseminomatous germ-cell tumors (GCT) in one of the following groups: A) First relapse or progression or second response with an intermediate or high risk according to the Beyer model. B) Second relapse or beyond.
• Adequate renal glomerular and tubular function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL, and urinary protein excretion </=500 mg/day.
• Adequate hepatic function, as defined by ALT and AST </=3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase </=2 x ULN or considered not clinically significant.
• Adequate pulmonary function with FEV1 (Forced expiratory volume in the first second), FVC (Forced vital capacity) and DLCO (diffusing capacity of the lung for carbon monoxide) >/=50% of predicted, corrected for volume and hemoglobin.
• Adequate cardiac function with LVEF (left ventricular ejection fraction) >/=40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
• Zubrod performance status 0-2.
• A minimum apheresis collection of 5 million CD34+ cells/kg of autologous hematopoietic progenitor cells (AHPC).
• Written informed consent by patients and/ or their parents or legal guardians. Assent for those patients inclusive of ages 12 to 17.