CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 试验地点
- 10
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining arsenic trioxide and dexamethasone in treating patients who have recurrent or refractory stage II or stage III multiple myeloma.
详细描述
OBJECTIVES:
- Determine the response rate of patients with recurrent or refractory stage II or III multiple myeloma treated with arsenic trioxide and dexamethasone.
- Determine the rates of overall and relapse-free survival in patients treated with this regimen.
- Determine the safety profile of this treatment regimen in these patients.
OUTLINE: Patients receive arsenic trioxide IV daily for 5 days during the first week only and then 2 days a week thereafter. Patients also receive IV or oral dexamethasone on days 1-4 every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Disease assessments are conducted every 4 weeks. Patients achieving complete response (CR) receive 2 additional courses of therapy after initial determination of CR.
Final assessments are conducted 4 weeks after the last study treatment and then annually thereafter.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of stage II or III multiple myeloma
- •Refractory myeloma defined as progressive disease (more than 25% increase in M protein or in radiographic findings of nonsecretory myeloma) despite up to 3 courses of prior cytotoxic chemotherapy
- •No more than 3 prior cytotoxic regimens
- •No more than 1 prior high-dose cytotoxic regimen with stem cell transplantation
- •History of disease progression after prior steroid antimyeloma therapy
- •No smoldering myeloma
- •Measurable disease based on presence of serum and urine M protein and/or measurable plasmacytoma
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Absolute granulocyte count greater than 1,200/mm^3*
- •Platelet count greater than 75,000/mm^3*
- •Hemoglobin greater than 10 g/dL* NOTE: *Unless due to multiple myeloma
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •SGOT and SGPT no greater than 2 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •Absolute QT interval less than 460 msec in the presence of normal potassium and magnesium levels
- •No significant underlying cardiac dysfunction
- •No conduction defects
- •No unstable angina
- •No congestive heart failure
- •No New York Heart Association class II-IV cardiac disease
- •No myocardial infarction within the past 6 months
- •No preexisting grade 2 or greater neurotoxicity/neuropathy
- •No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
- •No uncontrolled diabetes mellitus
- •No active serious infection uncontrolled by antibiotics
- •No history of grand mal seizures (other than infantile febrile seizures)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •See Chemotherapy
- •At least 28 days since prior biologic therapy
- •Chemotherapy:
- •See Disease Characteristics
- •At least 28 days since prior cytotoxic chemotherapy, including high-dose cytotoxic regimen with stem cell transplantation
- •No other concurrent cytotoxic chemotherapy
- •Endocrine therapy:
- •See Disease Characteristics
- •Radiotherapy:
- •At least 28 days since prior radiotherapy except for focal radiation for symptom control
- •Not specified
排除标准
- 未提供