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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma  Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
For Condition: recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma,recurrent adult diffuse large cell lymphoma,recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent adult immunoblastic large cell lymphoma,recurrent grade I follicular small cleaved cell lymphoma,recurrent grade III follicular large cell lymphoma,recurrent adult diffuse mixed cell lymphoma,recurrent mantle cell lymphoma,recurrent adult diffuse small cleaved cell lymphoma,recurrent adult lymphoblastic lymphoma,recurrent grade II follicular mixed cell lymphoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , University of Iowa
Synopsis: RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent non-Hodgkin's lymphoma.
Details: OBJECTIVES: I. Assess the safety and tolerability of monoclonal antibody Hu1D10 in patients with previously treated non-Hodgkin's lymphoma expressing the antigen recognized by Hu1D10. II. Determine the maximum tolerated dose of monoclonal antibody Hu1D10 in these patients. III. Evaluate the pharmacokinetics, compare the pharmacology at different dose levels, and determine the optimal biological dose of this drug in these patients. IV. Evaluate any antilymphoma effects of this drug in these patients. PROTOCOL OUTLINE: This is a dose escalation, multicenter study. Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1, 8, 15, and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity. Once the MTD is determined, an additional cohort of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5. Patients are followed at 4 weeks, 50 days, and periodically thereafter until disease progression. PROJECTED ACCRUAL: A total of 2-35 patients will be accrued for this study over 9-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed non-Hodgkin's lymphoma in relapse or refractory to prior treatment; At least 50% of malignant cells on biopsy specimen reactive with the 1D10 antibody OR At least 50% of B cells within tumor reactive with 1D10 if extensive T cell infiltrations present - Measurable or evaluable disease - Circulating tumor cells fewer than 5,000/mm3 (in dose escalation phase only) - Not eligible for curative conventional therapy --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior interferon; Concurrent transfusions allowed - Chemotherapy: At least 4 weeks since prior cytotoxic chemotherapy; No concurrent antineoplastic agents - Endocrine therapy: At least 4 weeks since prior corticosteroids; No concurrent glucocorticoids - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: See Disease Characteristics; Platelet count at least 75,000/mm3 - Hepatic: Bilirubin less than 2.5 mg/dL; SGOT less than 3 times upper limit of normal - Renal: Creatinine less than 2.0 mg/dL - Cardiovascular: No New York Heart Association class III or IV heart disease - Pulmonary: No clinically significant pulmonary disease - Other: No active serious infection; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; HIV negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrianLink, Study Chair, University of Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Biologics Evaluation Section
Bethesda, Maryland, 20892-9903
United States
Additional Information:
Study ID Numbers: CDR0000067318; UIHC-UICC-LW-02,NCI-T99-0019
Study Start Date: November 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004101
Other Recurrent Grade Iii Follicular Large Cell Lymphoma Studies:
1. Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
2. Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
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 Relapsed or Refractory Non-Hodgkin's Lymphoma
5. Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent grade III follicular large cell lymphoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
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