Status:
COMPLETED
Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
Ortho Biotech, Inc.
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief 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 o...
Detailed 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 rela...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00244985
Start Date
September 1 2005
End Date
December 1 2012
Last Update
August 17 2017
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001