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Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia - Article


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Agalsidase Beta

Fabrazyme


Clinical Trial: Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia

This study has been suspended.

Sponsored by: LifeTime Pharmaceuticals
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
Waldenstrom's Macroglobulinemia
 Drug: beta alethine
 Procedure: biological response modifier therapy
 Procedure: non-specific immune-modulator therapy
Phase I
Phase II

MedlinePlus related topics:  Blood and Blood Disorders;   Immune System and Disorders;   Lymphatic Diseases;   Vascular Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of Beta Alethine in Patients With Waldenstrom's Macroglobulinemia

Further Study Details: 

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS: Age:

  • 18 and over

Performance status:

  • Karnofsky 50-100%

Life expectancy:

  • At least 4 months

Hematopoietic:

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

Hepatic:

  • 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

Renal:

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

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY: Biologic therapy:

Chemotherapy:

Endocrine therapy:

  • More than 4 weeks since prior corticosteroids
  • No concurrent corticosteroids

Radiotherapy:

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

Surgery:

  • Recovered from any prior surgery
  • No prior organ transplant

Other:


Location Information


Maryland
      Victory Over Cancer, Rockville,  Maryland,  20852,  United States

Study chairs or principal investigators

Suzin Mayerson, PhD,  Study Chair,  LifeTime Pharmaceuticals   

More Information

Study ID Numbers:  CDR0000069494; LIFETIME-LTP-01-03
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  July 8, 2002
ClinicalTrials.gov Identifier:  NCT00041379
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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October 16, 2008



Page Updated: June 1, 2005
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