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Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
beta alethine
Sponsored by
LifeTime Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Waldenström macroglobulinemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Victory Over Cancer

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 8, 2002
Last Updated
December 17, 2013
Sponsor
LifeTime Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00041379
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
LifeTime Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Waldenström macroglobulinemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
beta alethine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzin Mayerson, PhD
Organizational Affiliation
LifeTime Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Victory Over Cancer
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States

12. IPD Sharing Statement

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Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia

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