NCT00027742已完成2 期
A Phase II Study of Temozolomide (Temodar) and Peglated Interferon Alfa-2B (PEGIntron) in the Treatment of Advanced Melanoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma.
详细描述
OBJECTIVES:
- Determine the response rate in patients with advanced melanoma treated with temozolomide and pegylated interferon alfa.
- Determine the toxicity profile of this regimen in these patients.
- Determine the duration of disease response and overall survival of patients treated with this regimen.
OUTLINE: Patients are stratified according to CNS metastases (yes vs no).
Patients receive oral temozolomide once daily on weeks 1-6 and pegylated interferon alfa subcutaneously once weekly on weeks 1-8. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 23-61 patients (12-35 without CNS metastases and 11-26 with CNS metastases) will be accrued for this study within 18 months.
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 confirmed malignant melanoma
- •Unresectable stage III or stage IV disease
- •Ocular, mucosal, or cutaneous melanoma
- •Measurable disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 150,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT/SGPT no greater than 3 times ULN
- •Alkaline phosphatase no greater than 3 times ULN
- •Creatinine no greater than 1.5 times ULN OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No history of severe cardiovascular disease
- •No myocardial infarction within the past 6 months
- •No unstable angina
- •No New York Heart Association class III or IV heart disease (congestive heart failure)
- •No ventricular tachyarrhythmias
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No AIDS-related illness
- •No frequent vomiting or other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)
- •No serious infection requiring IV antibiotics
- •No psychiatric disorder requiring ongoing therapy or medication
- •No nonmalignant illness or other medical condition that would preclude study
- •No other active malignancy within the past 2 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer detected initially during transurethral resection of the prostate (TURP) (comprising less than 5% of resected tissue) with PSA level normal since TURP
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior biologic therapy or immunotherapy and recovered
- •No concurrent immunotherapy
- •Chemotherapy:
- •No prior dacarbazine
- •No prior temozolomide
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent systemic corticosteroids
- •Radiotherapy:
- •At least 3 weeks since prior radiotherapy, interstitial brachytherapy, or radiosurgery
- •At least 3 weeks since prior radiotherapy to the brain for brain metastases
- •Prior radiotherapy to indicator lesions allowed if there is evidence of disease progression
- •Recovered from prior radiotherapy
- 另有 2 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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