Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or 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 I trial to study the effectiveness of monoclonal antibody therapy in treating patients with refractory anaplastic large cell lymphoma or Hodgkin's lymphoma.

Detailed Description
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OBJECTIVES: Determine the safety and tolerability of multiple doses of monoclonal antibody HeFi-1 in patients with CD30+ anaplastic large cell lymphoma or Hodgkin's lymphoma. Determine the pharmacokinetics of this drug in this patient population. Evaluate the efficacy, in terms of correlating immunologic parameters and immunogenicity, of this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. Patients receive monoclonal antibody HeFi-1 IV over 30 minutes 3 times a week for 2 weeks. Treatment may continue for 2 additional weeks in the absence of anti-HeFi-1 response. Responding patients may continue treatment at monthly intervals for one year. Cohorts of 3-4 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity. Patients are followed monthly. PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.

Official Title
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HeFi-1 Antibody Therapy in Ki-1 and Hodgkin's Lymphomas, a Phase I Study

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: monoclonal antibody HeFi-1


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed CD30+ anaplastic large cell lymphoma (ALCL) or Hodgkin's lymphoma At least 50% of malignant cells must react with HeFi-1 HIV positive or HIV negative Measurable disease No symptomatic CNS disease Must have failed or be ineligible for standard chemotherapy regimen PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: More than 2 months Hematopoietic: Not specified Hepatic: No significant hepatic disease Bilirubin no greater than 2 mg/dL Renal: No significant renal disease Creatinine no greater than 3 mg/dL Cardiovascular: No significant cardiovascular disease Pulmonary: No significant pulmonary disease Other: No significant endocrine, rheumatologic, or allergic disease No active clinical disease caused by cytomegalovirus (CMV), herpes simplex virus (HSV) I, HSV II, hepatitis B, or tuberculosis Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine antibody therapy Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy to measurable disease Surgery: Not specified Other At least 4 weeks since prior cytotoxic therapy to measurable disease

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: monoclonal antibody HeFi-1|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, anaplastic large cell lymphoma