Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia

• ClinicalTrials.gov Identifier: NCT00041379
• Recruitment Status: Unknown
• First Posted: January 27, 2003
• Last Update Posted: December 18, 2013
• Sponsor: LifeTime Pharmaceuticals
• Information provided by: National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: July 8, 2002
• First Posted Date: January 27, 2003
• Last Update Posted Date: December 18, 2013
• Study Start Date: March 2002
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia
• Official Title: 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Primary Purpose: Treatment
• Condition: Lymphoma
• Intervention: Drug: beta alethine
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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:

• 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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00041379
• Other Study ID Numbers: CDR0000069494; LIFETIME-LTP-01-03
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: LifeTime Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Chair: Suzin Mayerson, PhD; LifeTime Pharmaceuticals

• PRS Account: National Cancer Institute (NCI)
• Verification Date: December 2005