Trial Search Results

Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)


  • Drug: Gemcitabine
  • Drug: Vinorelbine
  • Drug: Carmustine
  • Drug: Etoposide
  • Drug: Cyclophosphamide
  • Procedure: Autologous HCT


Phase 2


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.

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
Not Recruiting