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Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 8, 2002
Last updated: December 17, 2013
Last verified: December 2005

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 Intervention Phase
Lymphoma Drug: beta alethine Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2002
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00041379

United States, Maryland
Victory Over Cancer
Rockville, Maryland, United States, 20852
Sponsors and Collaborators
LifeTime Pharmaceuticals
Study Chair: Suzin Mayerson, PhD LifeTime Pharmaceuticals
  More Information Identifier: NCT00041379     History of Changes
Other Study ID Numbers: CDR0000069494
Study First Received: July 8, 2002
Last Updated: December 17, 2013

Keywords provided by National Cancer Institute (NCI):
Waldenström macroglobulinemia

Additional relevant 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
Cystine Depleting Agents
Molecular Mechanisms of Pharmacological Action processed this record on July 24, 2017