monoclonal antibody therapy in treating patients with advanced or recurrent lymphoma

Conditions: Lymphoma; Small Intestine Cancer

Summary: 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.

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.

Eligibility criteria:
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

Keywords: 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