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Sponsors and Collaborators: |
Holden Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004101 |
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.
Condition | Intervention | Phase |
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Lymphoma |
Biological: apolizumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of Humanized 1D10 Monoclonal Antibody (Hu1D10) In Patients With Relapsed Non-Hodgkin's Lymphoma (NHL) |
Study Start Date: | November 1999 |
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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
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
United States, District of Columbia | |
Walter Reed Army Medical Center | |
Washington, District of Columbia, United States, 20307-5000 | |
United States, Iowa | |
University of Iowa Hospitals and Clinics | |
Iowa City, Iowa, United States, 52242 | |
United States, Maryland | |
Biologics Evaluation Section | |
Bethesda, Maryland, United States, 20892-9903 | |
Johns Hopkins Oncology Center | |
Baltimore, Maryland, United States, 21231 | |
United States, New York | |
New York Presbyterian Hospital - Cornell Campus | |
New York, New York, United States, 10021 |
Study Chair: | Brian Link, MD | Holden Comprehensive Cancer Center |
Study ID Numbers: | CDR0000067318, UIHC-UICC-LW-02, NCI-T99-0019 |
Study First Received: | December 10, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004101 History of Changes |
Health Authority: | United States: Federal Government |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma |
recurrent adult Burkitt lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Immunologic Factors Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Mantle Cell Lymphoma Follicular Lymphoma Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Antibodies, Monoclonal Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Immunoblastic Leukemia, B-cell, Chronic |
Lymphoma, Large-cell Lymphoma Immunoglobulins Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Recurrence Lymphatic Diseases Burkitt's Lymphoma Chronic Lymphocytic Leukemia Antibodies B-cell Lymphomas Burkitt Lymphoma Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
Antibodies, Monoclonal Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Pharmacologic Actions |