NCT00030589Unknown2 期
A Muliticenter, Dose-Reandomized Evaluation Of Targretin Capsules Plus PUVA In Patients With Stage IB - IIA Cutaneous T-Cell Lymphoma
Millennix35 个研究点 分布在 1 个国家开始时间: 2001年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 35
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. Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. Photosensitizing drugs, such as methoxsalen, are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells. Combining chemotherapy with photodynamic therapy may be an effective treatment for cutaneous T-cell lymphoma.
PURPOSE: Randomized phase II trial to study the effectiveness of combining different doses of bexarotene with photodynamic therapy in treating patients who have stage IB or stage IIA cutaneous T-cell lymphoma.
详细描述
OBJECTIVES:
- Compare the efficacy of 2 different doses of bexarotene administered with ultraviolet A light therapy with methoxsalen (PUVA) in patients with stage IB or IIA cutaneous T-cell lymphoma.
- Compare the safety of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive a lower dose of oral bexarotene once daily on weeks 1-26. Patients also receive ultraviolet A light therapy with oral methoxsalen 3 times weekly on weeks 2-26.
- Arm II: Patients receive a higher dose of oral bexarotene once daily on weeks 1-26. Patients also receive ultraviolet A light therapy as in arm I.
Patients are followed at 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
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 confirmed cutaneous T-cell lymphoma within the past year
- •Stage IB or IIA disease
- •No prior diagnosis more advanced than stage IIA disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Hemoglobin at least 9 g/dL
- •WBC at least 2,000/mm^3
- •Absolute lymphocyte count normal
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •AST and ALT no greater than 2.5 times ULN
- •No significant hepatic dysfunction
- •Creatinine no greater than 2 times ULN
- •Calcium no greater than 11.5 mg/dL
- •No significant renal dysfunction
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 1 month after study participation
- •Fasting triglycerides normal (fenofibrate or another anti-lipemic agent allowed except gemfibrozil)
- •HIV negative
- •No other concurrent known serious medical illness or infection that would preclude study participation
- •No prior uncontrolled hyperlipidemia
- •No pancreatitis or clinically significant risk factors for developing pancreatitis
- •No known allergy or sensitivity to retinoid class drugs or fenofibrate or idiosyncratic reactions to psoralen compounds
- •No history of light-sensitive disease states (e.g., lupus, porphyria, or albinism) or aphakia
- •No prior or concurrent melanoma or invasive squamous cell carcinoma
- •No pre-existing gallbladder disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior systemic anticancer interferon
- •No prior systemic anticancer denileukin diftitox
- •Chemotherapy:
- •At least 30 days since prior topical anticancer carmustine or mechlorethamine
- •No prior systemic anticancer alkaloid chemotherapy
- •No other concurrent systemic or topical anticancer chemotherapy (e.g., methotrexate or cyclophosphamide)
- •Endocrine therapy:
- •At least 30 days since prior topical anticancer corticosteroids
- •No concurrent systemic or topical anticancer corticosteroids
- •Radiotherapy:
- •No concurrent localized radiotherapy to specific study lesions except at investigator's discretion
- •Not specified
- •No prior systemic anticancer therapy
- •At least 30 days since prior topical anticancer therapy (e.g., ultraviolet B light or psoralen-ultraviolet-light therapy)
- •At least 30 days since prior participation in another investigational drug study
- •At least 30 days since prior vitamin A (at doses of more than 15,000 IU/day) or other retinoid class drugs
- 另有 5 项未显示
排除标准
- 未提供
研究者
研究点 (35)
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