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

Not Recruiting

Trial ID: NCT00388349

Purpose

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

Official Title

Gemcitabine and High-dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease

Stanford Investigator(s)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

Eligibility


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.

Intervention(s):

drug: Vinorelbine

drug: Carmustine

drug: Gemcitabine

drug: Etoposide

drug: Cyclophosphamide

procedure: Autologous HCT

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
6507230822

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