Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia

NCT00041379 | Unknown Phase 1

• 2 other identifiers: CDR0000069494LIFETIME-LTP-01-03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

Waldenström macroglobulinemia

Interventions

beta alethine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• LifeTime Pharmaceuticals: lead

Study Sites (1)

Victory Over Cancer

Rockville, Maryland, 20852, United States

Location

MeSH Terms

Conditions

Lymphoma; Waldenstrom Macroglobulinemia

Interventions

alethine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Suzin Mayerson, PhD

  LifeTime Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: March 1, 2002
• Last Updated: December 18, 2013

Record last verified: 2005-12

Locations

US (1)