Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease
Condition: Hodgkin Disease; Hodgkin's Lymphoma; Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Gemcitabine; Vinorelbine; Carmustine; Etoposide; Cyclophosphamide; Autologous HCT
Intervention MeSH terms: Cyclophosphamide; Carmustine; Gemcitabine; Etoposide; Vinorelbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood
      stem cell (PBSC) rescue for Hodgkin's Disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically-proven recurrent or refractory Hodgkin's Disease (Hodgkin's lymphoma)
             on the basis of excisional biopsy whenever possible.

          -  Age < 70 years

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3.

          -  Phase 1 study component only: 1 or more of the following adverse risk factors

               -  Stage IV extranodal disease at relapse "B" symptoms

               -  Failure to achieve minimal disease with most recent chemotherapy (single lymph
                  nodes < 2 cm or >75% reduction in a bulky tumor mass and bone marrow involvement
                  < 10%)

               -  Progression during induction or salvage therapy

          -  Phase 2 study component only: No risk factor criteria

          -  Computerized tomography (CT) scan of the chest, abdomen and pelvis, with assessment of
             response to last chemotherapy, within 4 weeks of registration. Gallium scan or
             positron emission tomography (PET) scan confirmation of disease within 4 weeks of
             registration is highly recommended

          -  Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration

          -  Women of child-bearing potential and sexually active males expected to use an accepted
             and effective method of birth control

          -  Pretreatment serum bilirubin < 2 x the institutional upper limit of normal (ULN)
             (within 28 days prior to registration)

          -  Serum creatinine < 2 x the institutional ULN (within 28 days prior to registration)

          -  Measured or estimated creatinine clearance > 60 cc/min by the following formula
             (within 28 days prior to registration):

               -  Estimated Creatinine Clearance = (140 age) x WT(kg) x 0.85 (if female) x
                  creatinine (mg/dL)

          -  Electrocardiogram (ECG) demonstrating no significant abnormalities suggestive of
             active cardiac disease (within 42 days prior to registration)

          -  Patients over age 50, who have received chest irradiation or a total of 300 mg/m2 of
             doxorubicin or with any history of cardiac disease must have a radionuclide ejection
             fraction (within 42 days prior to registration). If the ejection fraction is 40 to
             50%, the patient will have a cardiology consult

          -  Corrected diffusion capacity > 55%

          -  Written informed consent in accordance with institutional and federal guidelines

        Exclusion Criteria:

          -  Positive HIV antibody test (must be conducted within 42 days of registration)

          -  No chemotherapy other than corticosteroids should be administered within 2 weeks of
             the initiation of protocol therapy

          -  Pregnant

          -  Breast-feeding

          -  Requiring therapy for:

               -  Coronary artery disease

               -  Cardiomyopathy

               -  Dysrhythmia, or

               -  Congestive heart failure

          -  Over age 50 and has received chest irradiation or a total of 300 mg/m^2 of doxorubicin

          -  History of cardiac disease and the ejection fraction is < 40% (radionuclide ejection
             fraction must be within 42 days of registration)

          -  Known allergy to etoposide

          -  History of Grade 3 hemorrhagic cystitis with cyclophosphamide

          -  History of grade 2 or greater sensory or motor peripheral neuropathy due to prior
             vinca alkaloid use

          -  No prior malignancy (EXCEPTION: adequately treated basal cell or squamous cell skin
             cancer; in situ cervical cancer; or other cancer for which the patients has been
             disease-free for 5 years). Patients with a prior diagnosis of non-Hodgkin's lymphoma
             are not eligible.