Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia

Lymphoma Clinical Trial

Official title:

Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Waldenstrom's Macroglobulinemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00041379
• Other study ID #: CDR0000069494
• Secondary ID: LIFETIME-LTP-01-
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: July 8, 2002
• Last updated: December 17, 2013
• Start date: March 2002

Study information

• Verified date: December 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Waldenstrom Macroglobulinemia

Intervention

Drug:
• beta alethine

Locations

Country	Name	City	State
United States	Victory Over Cancer	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
LifeTime Pharmaceuticals

Country where clinical trial is conducted

United States,