Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma
Mantle Cell Lymphoma, Lymphoma, Mantle Cell
About this trial
This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring Lymphoma Vaccines, Immune Response Against Lymphoma, Molecular Complete Remissions, Novel Treatment Approach, Mantle Cell Lymphoma
Eligibility Criteria
INCLUSION CRITERIA: Tissue diagnosis of mantle cell lymphoma (confirmed in Laboratory of Pathology). Blastic cell variant will be eligible. Age greater than or equal to 18. Previously untreated with cytotoxic chemotherapy. Patients may have received local radiation or a short course of steroids for control of symptoms. All stages of disease. Lymph node of greater than or equal to 2 cm accessible for biopsy/harvest or greater than 1000/microliters of circulating tumor cells in the blood. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 3. Adequate major organ function (serum creatinine 1.5 mg/dl or creatinine clearance greater than 60 ml/min; bilirubin less than 2 mg/dl (total) except less than 5 mg/dl in patients with Gilbert's syndrome as defined by greater than 80% unconjugated; absolute neutrophil count (ANC) greater than 1000 and platelets greater than 100,000) unless impairment due to organ involvement by lymphoma. No active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year. If multigated acquisition (MUGA) scan is obtained, the left ventricular ejection fraction (LVEF) should exceed 40%. Ability to give informed consent. EXCLUSION CRITERIA: Antibodies to human immunodeficiency virus (HIV) or presence of hepatitis B surface antigen. Pregnant or lactating. Prior malignancy in past 5 years except squamous or basal cell carcinoma or curatively treated in situ of the cervix. Involvement of central nervous system by lymphoma.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Experimental
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).