Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma

Stanford University

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Lymphoma Small Intestine Cancer

Interventions

visilizumabBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University Medical Center

Stanford, California, United States

Data from ClinicalTrials.gov

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