Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent small lymphocytic lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of 1 of the following indolent or aggressive B-cell non-Hodgkin's lymphoma (NHL) subtypes: Grade 1-3 follicular lymphoma Mantle cell lymphoma Small lymphocytic lymphoma Diffuse large B-cell lymphoma Diffuse mixed cell lymphoma Marginal zone lymphoma Relapsed or refractory CD20-positive disease Measurable disease Must have received ≥ 1 but < 4 prior standard chemotherapy regimens No Burkitt's lymphoma or precursor B-lymphoblastic lymphoma No CNS lymphoma PATIENT CHARACTERISTICS: Performance status Karnofsky 60-100% Life expectancy At least 6 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 75,000/mm^3 Hemoglobin > 7 g/dL Hepatic AST or ALT < 2 times upper limit of normal (unless due to primary disease) Bilirubin ≤ 2 mg/dL Renal Creatinine ≤ 2.0 mg/dL Cardiovascular LVEF ≥ 50% by MUGA and/or 2-D echocardiogram No history of New York Heart Association class II-IV cardiac disease No congestive heart failure Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known HIV positivity No uncontrolled active bacterial, viral, or fungal infection No other serious disease that would preclude study participation No other primary malignancy within the past 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Recovered from prior immunotherapy Prior immunotherapy, including rituximab or other monoclonal antibody, allowed Chemotherapy See Disease Characteristics More than 4 weeks since prior chemotherapy and recovered No prior doxorubicin (or equivalent anthracycline) at a cumulative dose > 400 mg/m^2 No other concurrent chemotherapy Endocrine therapy Nonsteroidal hormones for nonlymphoma-related conditions (e.g., insulin for diabetes) allowed No concurrent corticosteroids except for a transient inflammatory reaction (i.e., skin rash or hives) Radiotherapy Recovered from prior radiotherapy No concurrent radiotherapy Surgery More than 4 weeks since prior major surgery (other than diagnostic surgery) and recovered Other No other concurrent antitumor agents No other concurrent investigational agents
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Experimental
Arm 1: Rituximab and Doxorubicin HCI Liposome
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3