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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma  Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
For Condition: recurrent grade III follicular large cell lymphoma,recurrent grade I follicular small cleaved cell lymphoma,recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent grade II follicular mixed cell lymphoma
Status: No longer recruiting
Sponsor(s): Protein Design Labs ,
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-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.
Details: OBJECTIVES: I. Compare the relative safety of 2 different doses of monoclonal antibody Hu1D10 in patients with relapsed or refractory grade I, II, or III B-cell non-Hodgkin's lymphoma. II. Compare the preliminary tumor response and progression-free survival of patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive lower-dose monoclonal antibody (MOAB) Hu1D10 IV over approximately 2 hours on days 1, 8, 15, and 22 in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive higher-dose MOAB Hu1D10 as in arm I. Patients are followed at weeks 1, 4, and 12, and then at months 6, 9, 12, 18, and 24. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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/mm3 --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 Surgery: Not specified Other: No other concurrent lymphoma therapy --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: - Platelet count at least 75,000/mm3 (unless disease related) - Neutrophil count at least 1,000/mm3 (unless disease related) - Hemoglobin greater than 8.0 g/dL Hepatic: - Bilirubin less than 2.5 mg/dL - SGOT less than 4 times upper limit of normal Renal: 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 Pulmonary: No clinically significant pulmonary disease Other: - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DanielLevitt, Study Chair, Protein Design Labs
Protein Design Labs, Inc.
Fremont, California, 94555
United States
Additional Information:
Study ID Numbers: CDR0000068585; CUMC-0101-552,PDL-1D10-901
Study Start Date: October 2000
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014664
Other Recurrent Diffuse Small Lymphocytic/marginal Zone Lymphoma Studies:
1. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
2. Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer
3. Radiation Therapy and Cyclophosphamide Plus Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non-Hodgkin's Lymphoma
4. Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
5. Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent diffuse small lymphocytic/marginal zone lymphoma Clinical Trials
Other California Clinical Trials
Other Fremont Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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