NCT00908141已完成2 期
Immunologic Effects of GM-CSF (Sargramostim, Leukine®) in Patients With Biochemically-relapsed Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Prostate Specific Antigen (PSA) Response
研究概览
简要总结
RATIONALE: Colony stimulating factors, such as GM CSF, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known which GM-CSF regimen is more effective in treating patients with prostate cancer.
PURPOSE: This randomized phase II trial is studying how well GM-CSF works in treating patients with relapsed prostate cancer.
详细描述
OBJECTIVES:
Primary
- To determine the ability of sargramostim (GM-CSF) to increase the number and activation of dendritic cells (DC) in patients with biochemically relapsed prostate cancer.
Secondary
- To determine the effect of administration schedule and hormonal state on sargramostim-induced DC number and activation in these patients.
- To correlate the effects of sargramostim on DC number and activation with effects on prostate-specific antigen (PSA) modulation.
- To determine whether sargramostim administration generates antiprostate cancer immune responses in these patients.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Non-metastatic, recurrent systemic disease as manifested by a rising PSA, defined as ≥ 2 consecutive rises in PSA to be documented over a reference value (measure 1)
- •The first rising PSA (measure 2) should be at taken ≥ 14 days after the reference value
- •A third confirmatory PSA measure is required (second beyond the reference level) to be greater than the second, and it must be obtained ≥ 14 days after the second measure
- •If this is not the case, a fourth PSA is required to be taken and be greater than the second measure
- •No local-only relapse
- •Must have undergone prior definitive therapy for prostate cancer consisting of external beam radiotherapy, brachytherapy (with or without external beam radiotherapy), or radical prostatectomy (with or without adjuvant androgen ablation)
- •Patients who have not undergone definitive therapy as above or who have undergone hormonal therapy alone are not eligible
- •No evidence of metastases on bone or CT scan
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Leukocytes ≥ 3,000/μl
- •Absolute neutrophil count ≥ 1,500/μl
- •Platelets ≥ 100,000/μl
- •Total bilirubin normal
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Creatinine ≤ 1.5 times ULN
- •No active thrombophlebitis or disseminated intravascular coagulopathy
- •No history of pulmonary embolus
- •No history of immunodeficiency or autoimmune diseases
- •No uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior systemic chemotherapy for any reason
- •No concurrent anticoagulation therapy (i.e., therapeutic coumadin)
- •Prophylactic anticoagulation (e.g., aspirin) allowed
- •No concurrent systemic corticosteroids or other immunosuppressives
- •Inhaled or topical steroids allowed
排除标准
- 未提供
研究组 & 干预措施
Arm II: sargramostim (3xweek)
Experimental
Patients receive GM-CSF SC three times weekly for 4 weeks. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: sargramostim (Biological)
Arm I: sargramostim (days1-14)
Experimental
Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-14. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: sargramostim (Biological)
结局指标
主要结局
Prostate Specific Antigen (PSA) Response
时间窗: post treatment at 9 weeks
The number of patients with PSA modulation defined as PSA decline of at least 50%
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic SyndromeMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative DiseasesLeukemiaNCT00003961Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
已完成
2 期
Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the LungKidney CancerMetastatic CancerNCT00006483Alliance for Clinical Trials in Oncology27
已完成
不适用
Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic AnemiaChronic Myeloproliferative DisordersMyelodysplastic/Myeloproliferative NeoplasmsGraft Versus Host DiseaseMyelodysplastic SyndromesLymphomaLeukemiaNCT00053157Roswell Park Cancer Institute10
已完成
2 期
GM-CSF and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Colon CancerColorectal CancerNCT00262808University of Rochester50
已完成
2 期
Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial TreatmentLeukemiaNCT00072579Wake Forest University Health Sciences