Beta Alethine in Treating Patients With Myeloma
This trial is active, not recruiting.
|Conditions||multiple myeloma and plasma cell neoplasm, precancerous condition|
|Phase||phase 1/phase 2|
|Start date||August 2000|
|Trial identifier||NCT00006466, CDR0000068280, LIFETIME-IRB-0300203, LIFETIME-LTP-99-01|
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 myeloma.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically proven myeloma - Multiple myeloma - Indolent myeloma with slowly progressive bone pathology - Smoldering myeloma with no bone pathology but a progressive increase in M-protein - Solitary myeloma OR - Diagnosis of evolving monoclonal gammopathy of undetermined significance with increasing M-protein or decreasing hemoglobin level - Measurable M-protein or Bence Jones protein - Indolent disease not requiring therapy allowed - 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: - See Disease Characteristics - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - 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 electrocardiogram - No uncontrolled angina, heart failure, or arrhythmia Other: - Adequate nutritional status (total protein at least 60.0 g/L, albumin at least 35 g/L) - HIV negative - No AIDS - No active bacterial infection (e.g., abscess) or with fistula - No history of alcoholism, drug addiction, or psychotic disorders that would preclude study - No other nonmalignant disease that would preclude study - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy or cytokines Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high-dose carboplatin) Endocrine therapy: - No concurrent corticosteroids Radiotherapy: - No prior radiotherapy to greater than 25% of bone marrow Surgery: - Recovered from any prior surgery - No prior solid organ transplantation Other: - No other concurrent investigational agent - No concurrent immunosuppressive agents - No concurrent anti-inflammatory agents, including aspirin or over-the-counter or prescription nonsteroidal anti-inflammatory drugs
|Official title||Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma|
|Description||OBJECTIVES: - Determine the antitumor effects of low-dose beta alethine in patients with myeloma or progressive monoclonal gammopathy of undetermined significance. - Determine the effects of this regimen on anemia, performance status, pain, and delayed-type hypersensitivity (immune response) in these patients. - Determine the safety of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive beta alethine subcutaneously every 2 weeks for 6 doses. At day 85, patients may receive an additional 12-week course of therapy in the absence of disease progression or unacceptable toxicity. Patients with an apparent complete response receive additional courses. Patients are followed for 2 weeks. PROJECTED ACCRUAL: A total of 13-37 patients will be accrued for this study.|
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