High-Dose Gemcitabine, Busulfan and Melphalan for Patients With Refactory Hodgkin's Disease
Condition: Lymphoma
MeSH terms: Hodgkin Disease
Intervention: Gemcitabine; Busulfan; Melphalan; Stem Cell Transplantation; Palifermin
Intervention description: 2775 mg/m2 by vein over about 3 hours on days -8 and -3.; 32 mg/m2 test dose with PKs as outpatient and on day -10 as inpatient
AUC 4,000 by vein over about 3 hours on days -8 to -5.; 60 mg/m2 by vein over about 30 minutes on days -3 and -2.; Infusion of stem cells on Day 0.; 60 mg/kg by vein over 30 seconds daily, Days -12 to -10 and Days 0 to 2.
Intervention MeSH terms: Gemcitabine; Melphalan; Busulfan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 12 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hodgkin's disease; Relapsed; Refractory; High-dose chemotherapy; Busulfan; Gemcitabine; Melphalan

Summary:

      The goal of this clinical research study is to learn if the combination of gemcitabine,
      busulfan, and melphalan, when given before a stem cell transplant, can help to control
      refractory Hodgkin's disease. The safety of this study treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 12 to 70 years

          2. 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.

          3. 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 </=1.8
             mg/dL.

          4. Adequate hepatic function, as defined by SGOT and/or SGPT </=3 x upper limit of
             normal; serum bilirubin and alkaline phosphatase </=2 x upper limit of normal, unless
             due to disease involvement

          5. Adequate pulmonary function with FEV1, FVC and DLCO >/=50% of expected corrected for
             hemoglobin and/or volume.

          6. Adequate cardiac function with left ventricular ejection fraction >/=40%. No
             uncontrolled arrhythmias or symptomatic cardiac disease.

          7. Zubrod performance status <2.

          8. Negative Beta HCG text in a woman with child-bearing potential, defined as not
             post-menopausal for 12 months or no previous surgical sterilization

        Exclusion Criteria:

          1. Patients with grade >/= 3 non-hematologic toxicity from previous therapy that has not
             resolved to </= grade 1.

          2. Patients with prior whole brain irradiation

          3. Patients with active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA
             >/=10,000 copies/mL, or >/= 2,000 IU/mL).

          4. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic
             hepatitis C or positive hepatitis C serology.

          5. Active infection requiring parenteral antibiotics.

          6. HIV infection, unless the patient is receiving effective antiretroviral therapy with
             undetectable viral load and normal CD4 counts

          7. 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.