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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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE July 8, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date December 18, 2013
Study Start Date  ICMJE March 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia
Official Title  ICMJE Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Waldenstrom's Macroglobulinemia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE Drug: beta alethine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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:

  • 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

Chemotherapy:

  • 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

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:

  • No other concurrent investigational agent
  • No concurrent immunosuppressants
  • No concurrent anti-inflammatory agents including aspirin and non-steroidal anti-inflammatory agents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00041379
Other Study ID Numbers  ICMJE CDR0000069494
LIFETIME-LTP-01-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE LifeTime Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Suzin Mayerson, PhD LifeTime Pharmaceuticals
PRS Account National Cancer Institute (NCI)
Verification Date December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP