Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma

Study Overview
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Brief Summary
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RATIONALE: Monoclonal 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 monoclonal antibody therapy in treating patients who have advanced or recurrent lymphoma.

Detailed Description
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OBJECTIVES: Determine the safety and tolerability of monoclonal antibody HuM291 in patients with advanced or recurrent CD3+ T-cell lymphomas. Evaluate the pharmacokinetics and pharmacodynamics of this treatment regimen in this patient population. Determine the response in these patients treated with this regimen. OUTLINE: This is a dose-escalation study. Patients receive monoclonal antibody HuM291 IV over 3 hours on days 1-4 in the absence of unacceptable toxicity. Patients achieving a partial response, complete response with recurrence, or stable disease may receive further therapy. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuM291 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed weekly for 1 month and then monthly for 3 months. PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study.

Official Title
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A Phase I, Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody (HuM291) in Patients With CD3+ T-cell Lymphomas

Conditions
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Lymphoma, Small Intestine Cancer

Intervention / Treatment
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* Biological: visilizumab


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed CD3+ T-cell lymphoma for which no standard curative therapy exists Peripheral T-cell lymphoma Recurrent and/or progressive disease after at least 1 prior therapy Mycosis fungoides Stage IB/IIA Recurrent and/or progressive disease after at least 2 prior therapies Stage IIB-IVB Recurrent and/or progressive disease after at least 1 prior therapy All other T-cell lymphomas Recurrent and/or progressive disease after at least 1 prior therapy Evaluable disease Any nodal site or mass lesion at least 1.5 cm in longest axis on physical exam or CT scan Skin lesions at least 1 cm in longest axis for cutaneous lymphoma High numbers of circulating T-cells allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC at least 2,000/mm^3* Absolute neutrophil count at least 1,000/mm^3* Platelet count at least 75,000/mm^3* NOTE: * Unless due to lymphoma Hepatic: Bilirubin no greater than 2.0 times normal* AST/ALT no greater than 2.5 times upper limit of normal* Hepatitis B and C negative NOTE: * Unless due to lymphoma Renal: Not specified Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No other uncontrolled illness No ongoing or active infection No other active malignancies except basal cell skin cancer or carcinoma in situ of the cervix HIV-1 negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics Biologic therapy: At least 60 days since prior humanized or chimeric antibody therapy Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified Other: At least 30 days since prior investigational drugs or therapies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: visilizumab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, small intestine lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, recurrent adult T-cell leukemia/lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, recurrent mycosis fungoides/Sezary syndrome