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

Completed · Phase 2

Conditions studied: Hodgkin Disease, Hodgkin's Lymphoma, Lymphoma

In brief

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

Key facts

Study ID: NCT00388349
Run by: Stanford University
People needed: 146
Starts: 2001-09-01
Expected to finish: 2010-09-01
Last updated by the study team: 2017-06-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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