Working… Menu

Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: beta alethine Phase 1 Phase 2

Detailed Description:


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Karnofsky 50-100%

Life expectancy:

  • At least 4 months


  • Neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 10 g/dL


  • 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


  • Creatinine no greater than 2.0 mg/dL
  • Creatinine clearance at least 60 mL/min


  • No acute changes on EKG
  • No uncontrolled angina
  • No heart failure
  • No arrhythmia


  • 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


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


  • 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


  • More than 4 weeks since prior radiotherapy involving more than 25% of bone marrow


  • Recovered from any prior surgery
  • No prior organ transplant


  • No other concurrent investigational agent
  • No concurrent immunosuppressants
  • No concurrent anti-inflammatory agents including aspirin and non-steroidal anti-inflammatory agents

Information from the National Library of Medicine

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 identifier (NCT number): NCT00041379

Layout table for location information
United States, Maryland
Victory Over Cancer
Rockville, Maryland, United States, 20852
Sponsors and Collaborators
LifeTime Pharmaceuticals
Layout table for investigator information
Study Chair: Suzin Mayerson, PhD LifeTime Pharmaceuticals
Layout table for additonal information Identifier: NCT00041379    
Other Study ID Numbers: CDR0000069494
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2005
Keywords provided by National Cancer Institute (NCI):
Waldenström macroglobulinemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases