Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease
Trial ID or NCT#
Status
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
Eligibility 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
- - 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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
BMT Referrals
6507230822
View on ClinicalTrials.gov