Non Hodgkin Lymphoma Clinical Trial
Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin’s Lymphoma
Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with liposomal doxorubicin may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects of giving rituximab together with liposomal doxorubicin and to see how well they work in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
Full Description
OBJECTIVES:
Primary
Determine the safety, including qualitative and quantitative toxic effects and their duration and reversibility, of rituximab and doxorubicin HCl liposome in patients with relapsed or refractory, indolent or aggressive CD20-positive B-cell non-Hodgkin's lymphoma.
Secondary
Determine the efficacy, including overall response rate and durability of objective response, of this regimen in these patients.
Correlate pretreatment functional, phenotypic, and genotypic characteristics of host immune effector cells with response in patients treated with this regimen.
OUTLINE: This is an open-label, pilot study.
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 4 years.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
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
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There is 1 Location for this study
Buffalo New York, 14263, United States
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