Monoclonal Antibody Therapy in Treating Patients With Recurrent or Refractory Lymphoma

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

Detailed Description
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OBJECTIVES: Determine the maximum tolerated dose and dose-limiting toxicity of monoclonal antibody mono-dgA-RFB4 in patients with recurrent or refractory B-cell lymphoma expressing CD22 antigen. Determine the pharmacokinetic profile of this drug in these patients. Correlate the pharmacokinetic parameters with the biologic effects and/or toxicity of this drug in these patients. Determine whether clinical responses in these patients occur at lower, equal, or higher doses than historical responses induced by a similar drug. OUTLINE: This is a dose-escalation study. Patients are stratified according to number of circulating tumor cells in peripheral blood (more than 50/mm3 vs 50/mm3 or less). Patients receive monoclonal antibody Mono-dgA-RFB4 IV over 4 hours on days 1, 3, and 5. Patients achieving complete, partial, or minimal remission receive additional courses of therapy every 4 weeks in the absence of unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody mono-dgA-RFB4 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients achieving complete remission or stable partial remission are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-18 months.

Official Title
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A Phase I Study Of Therapy With Mono-dgA-RFB4 In Patients With Relapsed And Refractory CD22+ B-Cell Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: monoclonal antibody mono-dgA-RFB4


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory B-cell lymphoma after at least 1 standard chemotherapy regimen Low, intermediate, or high grade CD22 antigen on at least 30% of tumor cells by flow cytometry No lymphoblastic lymphoma, B-cell chronic lymphocytic leukemia, B-cell or pre-B-cell acute lymphocytic leukemia, or hairy cell leukemia Measurable disease Positive bone marrow not considered measurable Circulating tumor cells in peripheral blood considered measurable No CNS disease (leptomeningeal or parenchymal) No lymphomatous or infectious pulmonary parenchymal disease No baseline/pleural effusion Ineligible for or refused autologous or allogeneic bone marrow transplantation NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of indolent or aggressive lymphoma will replace the former terminology of low, intermediate, or high grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count greater than 50,000/mm^3 Absolute granulocyte count greater than 750/mm^3 Hepatic: Bilirubin less than 1.5 mg/dL SGPT less than 2 times upper limit of normal Albumin greater than 75% lower limit of normal Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: Ejection fraction greater than 40% by MUGA or echocardiogram Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No human anti-mouse antibody (HAMA) levels greater than 1 microgram/mL No condition that may require stenting of ureters, stabilization of impending pathological fractures, or relief of airway, bowel, or biliary tract obstruction No other concurrent illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 2 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids unless receiving stable maintenance dose prior to therapy Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents

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: monoclonal antibody mono-dgA-RFB4|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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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 Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent small lymphocytic lymphoma