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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002765 |
RATIONALE: Immunotoxins 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 LMB-2 immunotoxin in treating patients who have leukemia or lymphoma.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma |
Biological: LMB-2 immunotoxin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | PHASE I STUDY OF ANTI-TAC(Fv)-PE38 (LMB-2), A RECOMBINANT SINGLE-CHAIN IMMUNOTOXIN FOR TREATMENT OF TAC-EXPRESSING MALIGNANCIES |
Study Start Date: | April 1996 |
OBJECTIVES:
OUTLINE: This is a dose escalation study.
Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats every 15-21 days for up to 10 courses in the absence of disease progression, neutralizing antibodies, or unacceptable toxicity.
Cohorts of 3-6 patients each receive escalating doses of LMB-2 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 patient experiences dose limiting toxicity.
PROJECTED ACCRUAL: A maximum of 40 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:
Histologically confirmed Hodgkin's disease, non-Hodgkin's lymphoma, or leukemia in one of the following categories:
Adult T-cell leukemia or lymphoma (ATL)
Cutaneous T-cell lymphoma (CTCL)
Stages I-IV peripheral T-cell lymphoma
B-cell non-Hodgkin's lymphoma (NHL) of any histology
Indolent stages II-IV NHL
Aggressive NHL
Chronic lymphocytic leukemia (CLL)
Primary B-cell prolymphocytic leukemia or prolymphocytic transformation of CLL
Hairy cell leukemia
Acute myelogenous leukemia
Stages II-IV Hodgkin's disease
Evidence of interleukin-2 receptor-alpha (IL2Ra) expression by one of the following:
No CNS disease requiring treatment
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
Laboratory of Molecular Biology | |
Bethesda, Maryland, United States, 20892 | |
Medicine Branch | |
Bethesda, Maryland, United States, 20892 |
Study Chair: | Robert Kreitman, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000064729, NCI-96-C-0064F, NCI-T95-0042N |
Study First Received: | November 1, 1999 |
Last Updated: | February 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00002765 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma Waldenstrom macroglobulinemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia refractory hairy cell leukemia recurrent small lymphocytic lymphoma 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 stage I adult T-cell leukemia/lymphoma stage II adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma recurrent adult T-cell leukemia/lymphoma prolymphocytic leukemia recurrent mantle cell lymphoma stage IV mycosis fungoides/Sezary syndrome recurrent mycosis fungoides/Sezary syndrome recurrent marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue |
Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Mycoses Acute Myelocytic Leukemia Leukemia, Prolymphocytic Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hairy Cell Leukemia Leukemia, Myeloid Waldenstrom Macroglobulinemia |
B-cell Lymphomas Leukemia, T-Cell Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Leukemia, Lymphoid Immunologic Factors Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Sezary Syndrome Mycosis Fungoides Leukemia, Myeloid, Acute Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell |
Lymphatic Diseases Leukemia Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Lymphoproliferative Disorders Lymphoma Pharmacologic Actions Immunotoxins |