A Phase 1 interventional study of LMB-2 immunotoxin in Leukemia and Lymphoma, sponsored by National Cancer Institute (NCI). Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-29.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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.
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.
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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:
This study is completed, as verified in Mar 2003. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)