High-Dose Gemcitabine, Busulfan and Melphalan for Patients With Refactory Hodgkin's Disease

Inclusion Criteria

• Age 12 to 70 years
• Patients with relapsed Hodgkin's disease and one or more of the following: 1) Less than complete response to first-line chemotherapy, 2) Relapse within 12 months of completion of first-line chemotherapy, 3) Relapse within a prior irradiation field, 4) Less than complete metabolic response to second-line chemotherapy, 5) Second relapse or beyond, 6) Extranodal disease at the time of relapse, 7) Presence of B symptoms at the time of persistent disease upon completion of first-line chemotherapy, or of relapse, progressive disease, 8) Bulky disease (defined as any lesion greater than 5 cm) at the time of persistent disease upon completion of first-line chemotherapy, or of relapse, progressive disease.
• Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min (using the Cockcroft-Gault formula: creatinine clearance = [(140-age)*kg/(72*serum creatinine)] * 0.85 if female) and/or serum creatinine /=50% of expected corrected for hemoglobin and/or volume.
• Adequate cardiac function with left ventricular ejection fraction >/=40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
• Zubrod performance status /= 3 non-hematologic toxicity from previous therapy that has not resolved to /=10,000 copies/mL, or >/= 2,000 IU/mL).
• Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
• Active infection requiring parenteral antibiotics.
• HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts
• Patients having received radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment.