Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia

Study Overview
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Brief Summary
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RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients who have Waldenstrom's macroglobulinemia.

Detailed Description
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OBJECTIVES: Determine the antitumor effects of low-dose beta alethine in patients with Waldenstrom's macroglobulinemia. Determine the effects of this drug on anemia, performance status, and disease symptoms in these patients. Determine the effects of this drug on the immune system of these patients. Determine the safety of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive beta alethine subcutaneously on days 1, 15, 29, 43, 57, and 71. Courses repeat every 85 days in the absence of disease progression or unacceptable toxicity. Patients are followed for 30 days. PROJECTED ACCRUAL: A total of 13-37 patients will be accrued for this study.

Official Title
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Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Waldenstrom's Macroglobulinemia

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: beta alethine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Confirmed diagnosis of Waldenstrom's macroglobulinemia Urine or serum protein electrophoresis showing a measurable monoclonal spike Indolent disease not yet requiring therapy allowed Positive delayed-type hypersensitivity (DTH) response Induration greater than 2 mm for at least 1 antigen No clinical signs or evidence of active brain involvement or leptomeningeal disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: At least 4 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Albumin at least 3.5 g/dL Bilirubin less than 2.0 mg/dL Transaminases no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No acute changes on EKG No uncontrolled angina No heart failure No arrhythmia Other: Adequate nutritional intake as evidenced by total protein at least 60 g/L Not pregnant or nursing Fertile patients must use effective contraception No concurrent gastrointestinal bleed No active bacterial infections such as abscess or with fistulae HIV negative No other concurrent non-malignant disease that would preclude study No history of alcoholism, drug addiction, or psychotic disorders that would preclude follow-up PRIOR CONCURRENT THERAPY: Biologic therapy: More than 4 weeks since prior immunotherapy More than 4 weeks since prior cytokines More than 4 weeks since prior plasmapheresis or plasma exchange No prior stem cell or bone marrow transplant Chemotherapy: More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high-dose carboplatin) No prior intensive chemotherapy with stem cell support Endocrine therapy: More than 4 weeks since prior corticosteroids No concurrent corticosteroids Radiotherapy: More than 4 weeks since prior radiotherapy involving more than 25% of bone marrow Surgery: Recovered from any prior surgery No prior organ transplant Other: No other concurrent investigational agent No concurrent immunosuppressants No concurrent anti-inflammatory agents including aspirin and non-steroidal anti-inflammatory 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 |
| --- |
|Drug: beta alethine|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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Waldenström macroglobulinemia