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Spots Global Cancer Trial Database for Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia

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Trial Identification

Brief Title: Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia

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

Study ID: NCT00041379

Conditions

Lymphoma

Interventions

beta alethine

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Victory Over Cancer, Rockville, Maryland, United States

Contact Details

Name: Suzin Mayerson, PhD

Affiliation: LifeTime Pharmaceuticals

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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