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Sponsors and Collaborators: |
Norris Cotton Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00014560 |
RATIONALE: Antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of antibody therapy in treating patients who have refractory or relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma |
Drug: bispecific antibody 4G7xH22 Drug: sargramostim |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial Of Intravenous Bispecific Antibody (4G7XH22) In Patients With Refractory Or Relapsed Non-Hodgkin's Lymphoma Or Chronic Lymphocytic Leukemia (CLL) |
Study Start Date: | September 2000 |
OBJECTIVES:
OUTLINE: This is a dose escalation study of bispecific antibody (BsAb) 4G7xH22.
Patients receive sargramostim (GM-CSF) subcutaneously on day 1 and BsAb 4G7xH22 IV over 2 hours on day 2. Treatment repeats weekly for a total of 3 courses in the absence of unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BsAb 4G7xH22 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity.
Patients are followed weekly for 4 weeks, monthly for 3 months, and then periodically for 1 year.
PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of CD19+ non-Hodgkin's lymphoma or chronic lymphocytic leukemia
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New Hampshire | |
Norris Cotton Cancer Center | |
Lebanon, New Hampshire, United States, 03756-0002 |
Study Chair: | Pamela Ely, MD | Norris Cotton Cancer Center |
Study ID Numbers: | CDR0000068556, DMS-9806, NCI-G01-1936 |
Study First Received: | April 10, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00014560 |
Health Authority: | United States: Federal Government |
refractory chronic lymphocytic leukemia 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 small lymphocytic lymphoma |
Leukemia, Lymphoid Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoma, large-cell, immunoblastic Antibodies, Bispecific Lymphoma, large-cell Leukemia Burkitt's lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Immunoblastic Lymphoma Immunoglobulins Chronic lymphocytic leukemia |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Leukemia, B-cell, chronic Lymphoblastic lymphoma Mantle cell lymphoma Recurrence Lymphatic Diseases Antibodies Burkitt Lymphoma Lymphoproliferative Disorders Leukemia, B-Cell Lymphoma, Non-Hodgkin Follicular lymphoma |
Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |