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Not Recruiting
Trial ID: NCT00388349
Gemcitabine and High-dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)
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.
drug: Vinorelbine
drug: Carmustine
drug: Gemcitabine
drug: Etoposide
drug: Cyclophosphamide
procedure: Autologous HCT
Not Recruiting
Stanford University
School of Medicine
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Stanford,
CA
94305
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