A Phase II Trial of COL-3 in Patients With HIV Related Kaposi's Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
COL-3 may stop the growth of cancer by stopping blood flow to the tumor. Randomized phase II trial to compare the effectiveness of two different regimens of COL-3 in treating patients who have HIV-related Kaposi's sarcoma.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the tumor response rate and response duration of treatment with Col-3 at two different dose levels- 50 mg/day and 100 mg/day in subjects with HIV related KS.
II. To evaluate the biologic activity of Col-3 by measuring percent apoptotic cells on tumor biopsies pre- and post-treatment.
III. To evaluate the effect of Col-3 on serum levels of MMP-2 and MMP-9.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Biopsy proven KS involving the skin , lymph nodes, oral cavity, gastrointestinal (GI) tract and/or lungs; GI and pulmonary involvement must be asymptomatic or minimally symptomatic and not require systemic cytotoxic therapy; at least five measurable, previously non-radiated, cutaneous lesions must be present which can be used as indicator lesions
- •Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive ELISA, positive Western Blot, or other federally approved licensed HIV test
- •Karnofsky performance status >= 60%
- •Hemoglobin >= 8.0 gm/dl
- •Absolute neutrophil count >= 750 cells/mm^3
- •Platelet count >= 75,000/mm^3
- •Serum creatinine =< 1.5 mg/dl or a measured creatinine clearance of > 60 ml/min
- •Total bilirubin should be normal; if, however, the elevated bilirubin is felt to be secondary to indinavir therapy, then subjects will be allowed on protocol if bilirubin < 3.5 mg/dl, provided that the direct bilirubin is normal
- •AST (SGOT) and ALT (SGPT) =< 2.5 times the ULN
- •PT and PTT < 120% of normal
- •Life expectancy of 3 months or more
- •Ability and willingness to give informed consent
- •All women of childbearing potential must have a negative serum beta HCG within 72 hours prior to study entry and must practice adequate birth control to prevent pregnancy while receiving study treatment and for 3 months after treatment is discontinued; all males of child fathering potential must also practice adequate birth control; pregnant or breast feeding females are excluded from participation in this study since the effects of Col-3 on an unborn or young child are unknown and may potentially be toxic
- •Subjects must, in the opinion of the investigator, be capable of complying with this protocol
排除标准
- •Concurrent active opportunistic infection (OI)
- •Concurrent neoplasia requiring cytotoxic therapy
- •Acute treatment for an infection or other serious medical illness within 14 days prior to study entry
- •Prior anti-neoplastic treatment for KS within 3 weeks of study entry; patients must also have completely recovered from any associated toxicity
- •Previous local therapy of any KS indicator lesion within 60 days, unless the lesion has progressed since treatment; because of the possibility of tattooing and the difficulty in ascertaining clinically what is active KS versus residual pigment post treatment, any prior local treatment to the indicator lesions regardless of the elapsed time should not be allowed unless there is evidence of clear-cut progression of said lesion
- •Anti-retroviral therapy is permitted but not required; if patients are taking anti-retroviral therapy, their regimen must not have changed within 4 weeks of starting the study medication; patient should be receiving an optimal and stable regimen of HAART for a minimum of 4 weeks prior to entry
- •Subjects must not have received blood products within 4 weeks of study entry and must not have received granulocyte colony stimulating factor or erythropoietin within 2 weeks of study entry
- •Evidence of a prior MI or cardiac ischemia
研究组 & 干预措施
Arm I (low dose incyclinide)
Patients receive low-dose oral COL-3 once daily.
Treatment on both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed.
干预措施: incyclinide (Drug)
Arm I (low dose incyclinide)
Patients receive low-dose oral COL-3 once daily.
Treatment on both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed.
干预措施: laboratory biomarker analysis (Other)
Arm II (high dose incyclinide)
Patients receive high-dose oral COL-3 once daily.
Treatment on both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed.
干预措施: incyclinide (Drug)
Arm II (high dose incyclinide)
Patients receive high-dose oral COL-3 once daily.
Treatment on both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Overall response rate
时间窗: Up to 6 years
Binomial proportions and their 95% confidence intervals will be used to estimate the overall response rate for each treatment group.
Response duration
时间窗: Up to 6 years
The Kaplan-Meier Method will be used to estimate the distribution of response duration for each treatment group.
次要结局
- Frequency of adverse events and their severity(Up to 6 years)
- Time to response(Up to 6 years)
- Quality of life(Up to 6 years)
- Relationship between clinical response and quantitative measures of KSHV/HHV8 and HIV viral load(Up to 6 years)