Clinical trial · Interventional
Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia
Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Waldenstrom's Macroglobulinemia
NCT00041379CI-TRIAL-00013025unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| beta alethine | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.