Immunotoxin in Treating Patients With Leukemia or Lymphoma
PHASE I STUDY OF ANTI-TAC(Fv)-PE38 (LMB-2), A RECOMBINANT SINGLE-CHAIN IMMUNOTOXIN FOR TREATMENT OF TAC-EXPRESSING MALIGNANCIES
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.
- Assess the therapeutic efficacy and toxicity of the recombinant immunotoxin LMB-2, an
anti-Tac murine monoclonal antibody fragment conjugated to a truncated portion of
Pseudomonas exotoxin, in patients with Tac-expressing leukemias and lymphomas.
- Define the pharmacokinetics of LMB-2, including the terminal elimination serum
half-life, area under the curve, and volume of distribution.
- Evaluate, in a preliminary manner, the immunogenicity of LMB-2 in these patients.
- Determine the effect of LMB-2 on various components of the circulating cellular immune
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.
recurrent adult Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, Waldenström 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, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
National Cancer Institute (NCI)
National Cancer Institute (NCI)
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