Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia

Phase 1

• Conditions: Lymphoma

• Registration Number: NCT00041379
• Lead Sponsor: LifeTime Pharmaceuticals

Brief 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.

Detailed 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 Timeline

• Study Start: 2002-03
• Study First Submitted: 2002-07-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2005-12
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Victory Over Cancer; 🇺🇸 Rockville, Maryland, United States