Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia
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|ClinicalTrials.gov Identifier: NCT00041379|
Recruitment Status : Unknown
Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: beta alethine||Phase 1 Phase 2|
- 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 Type :||Interventional (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|
|Study Start Date :||March 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041379
|United States, Maryland|
|Victory Over Cancer|
|Rockville, Maryland, United States, 20852|
|Study Chair:||Suzin Mayerson, PhD||LifeTime Pharmaceuticals|