Gemcitabine and High Dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease
Phase II Gemcitabine + HD Chemotherapy Followed by PBSC Rescue for HD
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Vinorelbine
- drug : Carmustine
- drug : Gemcitabine
- drug : Etoposide
- drug : Cyclophosphamide
- procedure : Autologous hematopoietic stem cell transplantation.
Phase: Phase 2
Ages Eligible For Study:
Histologically proven recurrent or refractory Hodgkin's lymphoma reviewed at Stanford University Medical Center. The diagnosis should be made by excisional biopsy whenever possible. Biopsy of refractory or recurrent disease is preferred but fine needle aspirate with supportive morphology and immunohistochemistry is acceptable for recurrent or persistent gallium-positive or positron emission tomography (PET)-positive radiographic disease when major surgery would be required. - Age < 70 years - ECOG performance status 0-3. - One or more adverse risk factors for Phase I study: - 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%) or progression during induction or salvage therapy. - Patients will be eligible regardless of risk factors for Phase II study. - Computerized tomography scan of the chest, abdomen and pelvis within 4 weeks of registration. Assessment of response to last chemotherapy prior to registration is mandatory. - Gallium scan or PET scan determination 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 are strongly advised to use an accepted and effective method of birth control. - Patients must have a pretreatment serum bilirubin < 2 x the institutional ULN, a serum creatinine < 2 x the institutional ULN and measured or estimated creatinine clearance > 60 cc/min by the following formula (all tests must be performed within 28 days prior to registration): - Estimated Creatinine Clearance = (140 age)X WT(kg) X 0.85 if female X creatinine (mg/dl) - Patients must have an EKG within 42 days prior to registration that shows no significant abnormalities that are suggestive of active cardiac disease. - Patients over age 50, those who have received chest irradiation or a total of 300 mg/m2 of doxorubicin, or those with any history of cardiac disease must have a radionuclide ejection fraction within 42 days of registration. If the ejection fraction is 40-50%, the patient will have a cardiology consult. - Patients must have a corrected diffusion capacity >55%. - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.