NCT00005074已完成2 期
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 4
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.
PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have previously untreated or relapsed mantle cell lymphoma.
详细描述
OBJECTIVES:
- Assess the efficacy of flavopiridol in terms of response rate in patients with previously untreated or relapsed mantle cell lymphoma.
- Assess the toxicity of this regimen in this patient population.
- Determine the time to progression and, if responses are observed, response duration in these patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour daily for 3 days. Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 2 additional courses after documented CR. Patients with a partial response receive 2 additional courses after documented maximal tumor shrinkage. Patients with stable disease receive a maximum of 4 courses.
Patients are followed at 4 weeks and then every 3 months until relapse or death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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:
- •Histologically or cytologically confirmed mantle cell lymphoma (at initial diagnosis) nonrefractory to prior therapy or with no prior therapy
- •No documented disease progression while receiving prior chemotherapy
- •CD20 and CD5 positive
- •Presence of clinically and/or radiologically documented disease
- •At least 1 site of disease must be bidimensionally measurable
- •Bone lesions not considered bidimensionally measurable
- •Minimum indicator lesions must be:
- •Lymph nodes at least 1.5 cm x 1.5 cm by physical exam or spiral CT scan OR
- •Other nonnodal lesions at least 1 cm x 1 cm by MRI, CT scan, or physical exam
- •No known CNS involvement by lymphoma
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm3
- •Platelet count at least 75,000/mm3
- •Bilirubin no greater than 1.5 times upper limit or normal (ULN)
- •AST no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No clinically significant cardiac symptomatology
- •If history of cardiac disease, cardiac ejection fraction greater than 50%
- •No clinically significant pulmonary symptomatology
- •If history of symptomatic pulmonary disease:
- •FEV1, FVC, and TLC greater than 60% predicted
- •DLCO greater than 50% predicted
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Must be accessible for treatment and follow-up (i.e., no geographical limitations)
- •No uncontrolled bacterial, fungal, or viral infection
- •No other serious concurrent disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior radioactive monoclonal antibody therapy
- •Prior rituximab allowed
- •Chemotherapy:
- •See Disease Characteristics
- •No more than 2 prior chemotherapy regimens allowed
- •Same chemotherapy combination given for first line and second line therapy considered 2 regimens
- •At least 6 weeks since prior chemotherapy
- •No prior high-dose chemotherapy and stem cell transplantation
- •No other concurrent cytotoxic chemotherapy
- •Endocrine therapy:
- •No concurrent corticosteroids
- •Radiotherapy:
- 另有 5 项未显示
排除标准
- 未提供
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
Flavopiridol in Treating Patients With Metastatic Malignant MelanomaMelanoma (Skin)NCT00005971NCIC Clinical Trials Group17
已完成
2 期
Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue SarcomaSarcomaNCT00005974NCIC Clinical Trials Group18
已完成
2 期
Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial CancerEndometrial CancerNCT00023894Gynecologic Oncology Group
已完成
2 期
Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney CancerKidney CancerNCT00016939SWOG Cancer Research Network
已完成
1 期
Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid TumorsMelanoma (Skin)Unspecified Adult Solid Tumor, Protocol SpecificBreast CancerProstate CancerNCT00003690Mayo Clinic48