Monoclonal Antibody Therapy in Treating Patients With Recurrent Hodgkin's 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 II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have progressive or recurrent Hodgkin's lymphoma.

Detailed Description
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OBJECTIVES: Determine the response rate of patients with recurrent Hodgkin's lymphoma treated with monoclonal antibody Hu1D10. Determine the duration of response and progression-free survival of patients treated with this drug. Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive monoclonal antibody Hu1D10 IV over 2 hours. Treatment repeats weekly for a total of 4 doses in the absence of disease progression or unacceptable toxicity. Patients are followed at weeks 5 and 8 and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within approximately 12 months.

Official Title
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A Phase II Study of Hu1D10 in Recurrent Hodgkin's Disease

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: apolizumab


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed Hodgkin's lymphoma Progressive or recurrent disease after standard initial therapy At least 1 unidimensionally measurable lesion (at least 15 mm by conventional techniques) Patients in first relapse must be ineligible or unwilling to receive high-dose therapy and stem cell transplantation Evidence of Hu1D10 localization to Reed Sternberg cells by immunohistochemistry No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy More than 6 months Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin normal AST and ALT no greater than 2.5 times upper limit of normal Renal Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation HIV negative No known human anti-human antibody No prior allergic reaction to compounds of similar chemical or biological composition to monoclonal antibody Hu1D10 No ongoing or active infection No other uncontrolled concurrent illness No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics See Chemotherapy Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Prior second-line (or greater) high-dose therapy and stem cell transplantation allowed Endocrine therapy Not specified Radiotherapy At least 4 weeks since prior radiotherapy and recovered Surgery Not specified Other No other concurrent investigational agents No other concurrent anticancer agents 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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: apolizumab|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 adult Hodgkin lymphoma