A Phase II Study of Liposomal Doxorubicin and Interleukin-12 in AIDS-Associated Kaposi's Sarcoma Followed by Chronic Administration of Interleukin-12
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 work in different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill the tumor cells. Combining chemotherapy with interleukin-12 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining liposomal doxorubicin with interleukin-12 in treating patients who have AIDS-related Kaposi's sarcoma.
详细描述
OBJECTIVES:
- Determine the overall response rate in patients with AIDS-associated Kaposi's sarcoma (KS) treated with doxorubicin HCl liposome and interleukin-12.
- Determine the time to response and the number of complete responses in patients treated with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
- Provide pilot information on the ability of interleukin-12 to maintain major responses induced with paclitaxel salvage therapy in patients with aggressive or life-threatening KS after treatment failure with doxorubicin HCl liposome and interleukin-12.
- Determine the effect of this regimen on CD4 counts and viral load in these patients.
OUTLINE: Patients receive doxorubicin HCl liposome (LipoDox) IV over 30 minutes once every 3 weeks for a total of 6 doses. Beginning concurrently with the initiation of LipoDox, patients also receive interleukin-12 (IL-12) subcutaneously twice weekly (at least 3 days apart) for up to 3 years.
Patients with refractory disease are transferred to the paclitaxel salvage therapy regimen comprising paclitaxel IV continuously on days 1-4 once every 3 weeks until a major response is achieved. Beginning concurrently with the initiation of paclitaxel salvage therapy, patients also receive IL-12 as above for up to 3 years.
Treatment continues in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response may discontinue IL-12 administration. If necessary, IL-12 treatment may resume at a later time.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed Kaposi's sarcoma (KS)
- •HIV positive
- •Evaluable disease involving the skin and/or viscera
- •At least 5 lesions not previously treated with local therapy if restricted to the skin
- •Pulmonary lesions evaluable by CT scan
- •Gastrointestinal lesions evaluable by visualization or fiberoptic instrumentation
- •Presence of at least one of the following indications for cytotoxic chemotherapy:
- •Pulmonary involvement
- •Visceral involvement
- •Ulcerating lesions
- •Decreased range of joint motion due to KS
- •Multiple lesions not amenable to local therapy
- •Lymphedema that impairs mobility or range of motion
- •Significant psychological impact leading to social withdrawal
- •Progressive disease within the past 3 weeks while receiving a stable regimen of highly active antiretroviral therapy for at least 4 weeks unless there is a need for urgent chemotherapy
- •Prior participation on this study allowed, provided patient was removed from study due to non-pancreatic hyperamylasemia and the following are true:
- •No dose-limiting toxicity by clinical and laboratory assessment
- •Pancreatic amylase portion normal by fractionated amylase
- •Lipase normal
- •No symptoms referable to the pancreas
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 30-100%
- •Life expectancy:
- •More than 2 months
- •Hematopoietic:
- •Hemoglobin at least 9.0 g/dL
- •Absolute neutrophil count at least 750/mm^3
- •Platelet count at least 75,000/mm^3
- •Bilirubin no greater than 3.8 mg/dL with direct fraction no greater than 0.3 mg/dL and indirect fraction no greater than 3.5 mg/dL if due to protease inhibitor therapy
- •PT or aPTT no greater than 120% of control unless due to lupus-type anticoagulant
- •AST no greater than 2.5 times upper limit of normal
- •No prior hepatic cirrhosis
- •No hepatic dysfunction
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No congestive heart failure
- •Ejection fraction at least 40% by MUGA or echocardiogram
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for 2 months after study participation
- •No clinically significant autoimmune disease
- •No active, gross gastrointestinal bleeding or uncontrolled peptic ulcer disease
- •No prior inflammatory bowel disease
- •No other prior or concurrent malignancy except squamous cell carcinoma in situ of the cervix or anus, completely resected basal cell carcinoma, or malignancy in complete remission for at least 1 year from the time a response was first documented
- •No severe or life-threatening infection within the past 2 weeks
- •No abnormality that would be scored as grade 3 toxicity except lymphopenia or direct manifestations of KS
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排除标准
- 未提供