NCT00006466Unknown1 期
Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 试验地点
- 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •Bilirubin less than 2.0 mg/dL
- •Transaminases no greater than 2.5 times upper limit of normal
- •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
- •Adequate nutritional status (total protein at least 60.0 g/L, albumin at least 35 g/L)
- •HIV negative
- •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
- •Recovered from any prior surgery
- •No prior solid organ transplantation
- •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
排除标准
- 未提供
研究者
研究点 (3)
Loading locations...
相似试验
Unknown
1 期
Beta Alethine in Treating Patients With Low-Grade LymphomaLymphomaNCT00007839LifeTime Pharmaceuticals
Unknown
1 期
Beta Alethine in Treating Patients With Waldenstrom's MacroglobulinemiaLymphomaNCT00041379LifeTime Pharmaceuticals
已完成
2 期
A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine Compared to a Marketed Combined Vaccine, Given to Healthy Children 4 to 6 Years of AgeMeasles; Mumps; Rubella; ChickenpoxMeaslesNCT05630846GlaxoSmithKline801
已完成
1 期
Safety and Immunogenicity Study of tgAAC09, a Gag-PR-RT AAV HIV VaccineHIV InfectionNCT00482027International AIDS Vaccine Initiative80
已完成
1 期
Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal CancerPeritoneal Cavity CancerOvarian CancerNCT00101257Fred Hutchinson Cancer Center18