NCT00026416Unknown2 期
Phase II Study of Low-Dose Interferon Alfa 2B (Schering Plough) Plus Thalidomide (Celgene) for Patients With Resected High-Risk Soft Tissue Sarcoma
Herbert Irving Comprehensive Cancer Center1 个研究点 分布在 1 个国家开始时间: 2001年10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
- 1
研究概览
简要总结
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Interferon alfa may interfere with the growth of cancer cells. Combining interferon alfa and thalidomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa and thalidomide in treating patients who have undergone surgery for soft tissue sarcoma or bone sarcoma.
详细描述
OBJECTIVES:
- Determine the efficacy of interferon alfa and thalidomide, in terms of time to disease progression, in patients with surgically resected high-risk soft tissue sarcoma or bone sarcoma.
- Determine the incidence of metastatic disease and overall survival in patients treated with this regimen.
- Determine the clinical and laboratory toxic effects and the tolerability of this regimen in these patients.
OUTLINE: Patients receive interferon alfa subcutaneously three times a week on weeks 1-60 and oral thalidomide once daily on weeks 13-60 in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks for at least 2 years.
PROJECTED ACCRUAL: A total of 20-48 patients will be accrued for this study.
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 primary or metastatic soft tissue sarcoma or bone sarcoma at high risk of recurrence
- •Grade III-IV tumor greater than 8 cm
- •Grade III-IV primary tumor greater than 5 cm with positive surgical margins
- •Grade III-IV primary tumor greater than 5 cm with distant metastases resected within 1 year of primary surgery
- •No more than 8 weeks since prior surgical resection of primary or metastatic disease
- •Ineligible for other high priority national or institutional study
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 2 months
- •Hematopoietic:
- •WBC greater than 3,000/mm^3
- •Neutrophil count at least 1,500/mm^3
- •Platelet count greater than 70,000/mm^3
- •Hemoglobin at least 10.0 g/dL
- •Bilirubin less than 2.0 mg/dL
- •SGOT or SGPT less than 3 times upper limit of normal (ULN)*
- •Alkaline phosphatase less than 3 times ULN*
- •No decompensated liver disease
- •No autoimmune hepatitis
- •No coagulation disorders NOTE: * Unless due to metastatic disease
- •Creatinine normal
- •Cardiovascular:
- •No history of severely debilitating cardiovascular disease
- •No unstable angina
- •No uncontrolled congestive heart failure
- •No thrombophlebitis
- •No history of severely debilitating pulmonary disease
- •No chronic obstructive pulmonary disease
- •No pulmonary embolism
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study
- •No acute infection requiring systemic antibiotics
- •No prior hypersensitivity to interferon alfa or any component of the injection
- •No diabetes mellitus prone to ketoacidosis
- •No severe myelosuppression
- •No history of autoimmune disease
- •No pre-existing thyroid abnormalities with thyroid function that cannot be maintained in the normal range
- •No clinically significant retinal abnormalities
- •No other serious medical or psychiatric illness that would preclude study
- •No prior malignancy except curatively treated carcinoma in situ of the cervix or skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Prior systemic chemotherapy allowed
- •Endocrine therapy:
- 另有 4 项未显示
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Interferon Alfa-2b With or Without Thalidomide in Treating Patients With Metastatic or Unresectable Kidney CancerKidney CancerNCT00005966Eastern Cooperative Oncology Group
已完成
2 期
Interferon Alfa and Thalidomide in Treating Patients With Stage IV MelanomaMelanoma (Skin)NCT00026520SWOG Cancer Research Network
已完成
2 期
Thalidomide in Treating Patients Who Have Undergone Surgery and Chemotherapy for Cancer That Has Spread Throughout the Abdomen Due to Colorectal Cancer or Appendix CancerCarcinoma of the AppendixColorectal CancerNCT00310076Wake Forest University Health Sciences29
已完成
2 期
PEG-Interferon Alfa-2b in Treating Patients With Stage IV MelanomaMelanoma (Skin)NCT00049530Eastern Cooperative Oncology Group32
Unknown
2 期
Interferon Alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney CancerKidney CancerNCT00027664Cancer Research UK90