NCT00014664UnknownPhase 2
A Phase II, Open-Label, Randomized, Multicenter Trial To Evaluate The Preliminary Safety And Efficacy of Hu1D10 In Patients With Relapsed Or Refractory Grades I, II, or III B-Cell Non-Hodgkin's Lymphoma (Including Follicular, Small Lymphocytic And Marginal Zone/MALT)
Conditions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- PDL BioPharma, Inc.
- Locations
- 1
Study Overview
Brief Summary
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different monoclonal antibody regimens in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES:
- Compare the relative safety of 3 different regimens of monoclonal antibody Hu1D10 in patients with relapsed or refractory grade I, II, or III B-cell non-Hodgkin's lymphoma.
- Compare the preliminary tumor response and progression-free survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive monoclonal antibody (MOAB) Hu1D10 IV over approximately 2 hours on days 1, 8, 15, and 22.
- Arm II: Patients receive MOAB Hu1D10 as in arm I at a higher dose.
- Arm III:Patients receive MOAB Hu1D10 IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26.
Treatment in all arms continues in the absence of disease progression or unacceptable toxicity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed relapsed or refractory grade I, II, or III non-Hodgkin's lymphoma (NHL), including follicular, small lymphocytic, or marginal zone/MALT lymphoma
- •Previously treated with radiotherapy, immunotherapy, and/or chemotherapy for NHL
- •Progression of disease or no response since last treatment for NHL
- •1D10+ lymphoma by immunohistochemistry or flow cytometry
- •Bidimensionally measurable disease at least 2 cm in a single dimension
- •No CNS metastases
- •Circulating tumor cells no greater than 5,000/mm^3
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Platelet count at least 75,000/mm^3 (unless disease related)
- •Neutrophil count at least 1,000/mm^3 (unless disease related)
- •Hemoglobin greater than 8.0 g/dL
- •Bilirubin less than 2.5 mg/dL
- •SGOT less than 4 times upper limit of normal
- •Creatinine less than 2.5 mg/dL
- •Cardiovascular:
- •No clinically significant cardiac disease (New York Heart Association class III or IV)
- •No evidence of myocardial infarction or cardiac arrhythmia (unless surgically repaired) within the past 6 months
- •No clinically significant pulmonary disease
- •No other malignancy within the past 2 years except non-melanoma skin cancer or carcinoma in situ
- •No significant psychiatric or CNS impairment
- •No active serious infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 1 month after study
- •Negative anti-Hu1D10 antibody response (HAHA/HAMA)
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •At least 4 weeks since prior interferon therapy
- •At least 3 months since prior immunotherapy
- •No prior monoclonal antibody Hu1D10
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior cytotoxic chemotherapy
- •Endocrine therapy:
- •At least 4 weeks since prior corticosteroids (more than 10 mg prednisone/day)
- •No concurrent corticosteroids at more than 10 mg prednisone/day for pre-existing diseases or adverse reactions
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior external beam radiotherapy
- •At least 3 months since prior radioimmunotherapy
- •Not specified
- •No other concurrent lymphoma therapy
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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