Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia

Lymphoma Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Waldenstrom Macroglobulinemia

• NCT number: NCT00041379
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: March 2002